Nom de l'organisation

LSI SOLUTIONS, Inc.

SRN

US-MF-000008267

Statut du fabricant

Actif

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• CONTRAINDICATIONS • The SEW-EASY® SYSTEM is not intended to be used with any suture other than a RAM® COR-SUTURE ® QUICK LOAD® suture in conjunction with a RAM® Suturing Device. • Do not use this suture under conditions in which excessive suture tension can lead to tissue damage.

  AUTRE

• WARNINGS • Endoscopic or minimally invasive procedures should only be performed by physicians having adequate training and familiarity with associated techniques. In addition, medical literature should be consulted relative to techniques, complications and hazards prior to the performance of such procedures. • Federal law restricts this device to sale, distribution and use by, or on, the order of a physician. • As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. • Do not resterilize. The SEW-EASY® DEVICE is designed and intended for single patient use only. Do not reuse, reprocess, or resterilize this product. The performance of the SEW-EASY® DEVICE after cleaning or other reprocessing has not been verified and is not supported by LSI Solutions, Inc. Reuse, reprocessing, or resterilization may compromise the integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. • Discard open (unsealed), unused, expired or damaged devices, or devices in damaged primary packaging. • Store at room temperature. Avoid prolonged exposure to elevated temperatures. • Users should be familiar with surgical procedures and techniques involving surgical suture before employing the SEW-EASY® SYSTEM, as risks may vary with the site of application and the suture material used. Proper orientation of the prosthesis is required. Avoid crossing or twisting suture. • Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

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• WARNINGS • Redundant, cut-away suture remnants, used needle caps, SEW-EASY® Cassettes, and SEW-EASY® Devices, along with packaging, must be inspected, handled and disposed of consistent with standard, accepted medical device disposal procedures. • The SEW-EASY® SYSTEM used in conjunction with RAM® COR-SUTURE ® QUICK LOAD® suture is not for use in neurological procedures. • Applications other than for soft tissue approximation, or to approximate soft tissue and prosthetic materials, can result in failure to pick up suture or in damage to the device making it unsuitable for continued use. • Never drive the needles into suture, pledgets, bone, dense ligamentous tissue, calcific tissue, metal features, stents, struts, components or other instruments. • Do not leave any foreign material (e.g. suture remnant, needle cap, etc.) unattached in areas potentially exposed to circulating blood. • If securing the RAM® COR-SUTURE ® QUICK LOAD® suture with any LSI SOLUTIONS® COR-KNOT® DEVICE (COR-KNOT® MIS DEVICE, COR-KNOT MINI® DEVICE), ensure any needle caps are removed from the suture ends being loaded, prior to loading the suture through the COR-KNOT® DEVICE. • The SEW-EASY® DEVICE is not intended for use in prosthetic materials through which the device needles cannot readily penetrate, based on the surgeon's judgment. • The SEW-EASY® valve handles are not intended for use with prosthetic valves with which the valve handle does not readily connect.

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• PRECAUTIONS • After each loading and re-loading of a new suture into a cassette, carefully inspect that the new needle caps are fully seated in the needle cap compartment. If the needle caps are not fully seated in the needle cap compartment, damage to the needles or needle caps may result, including fracturing off of the tips of the needles. • Do not use the SEW-EASY® SYSTEM to dissect or aggressively manipulate tissue structures. • Verify that the needle caps are still retained within the needle cap compartments and the device has not been damaged or deformed before attempting to place a stitch. • Do not manipulate the device at any time with the pink lever partially actuated. This may expose sharp surfaces that can cause trauma to the patient, the prosthesis, the device operator or other staff, or damage the device. • Ensure the advancing needles target and enter the needle cap compartment. For example, during the suture placement, avoid using an extended needle to manipulate or lift tissue or prosthetic because such an action can cause the needle to deviate from its targeted course toward the needle caps compartment. A needle tip not entering the needle cap compartment properly can strike the cassette tip of the device and lead to undesired outcomes, including needle tip fracture, missed needle cap, or non-needle cap pickup.

  AUTRE

• PRECAUTIONS • Check for hemostasis where appropriate. • The SEW-EASY® SYSTEM will not fit through standard laparoscopic cannulas with seals. • Before endoscopic instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility and ensure that electrical isolation or grounding is not compromised. • Ensure 3.5mm SEW-EASY® Cassettes are used only with 3.5mm SEW-EASY® Devices and 3.5mm RAM® Devices. Similarly, ensure 5mm SEW-EASY® Cassettes are used only with 5mm SEW-EASY® Devices and 5mm RAM® Devices. • Always assure cassette tip is viewed under direct visualization before advancing the needle. • Ensure that obstructions do not interfere with the firing of the SEW-EASY® SYSTEM; obstruction may cause damage to the needles. • If the prosthetic sewing cuff does not readily release from the cassette jaw, or the cassette does not readily release from the device, ensure pink lever is fully released. • Do not squeeze the pink lever of the SEW-EASY® SYSTEM while loading a RAM® COR-SUTURE ® QUICK LOAD® suture; squeezing the pink lever may expose the sharp needles and/or damage the needles. • In handling the SEW-EASY® SYSTEM, care should be taken to avoid jamming the suture into the needle cap compartment which can damage the needles. • Avoid damage to the needles, suture or needle caps due to direct application of surgical instruments, like forceps, needle holders, clamps, etc. • Adequate knot security requires accurate completion of accepted surgical techniques for constructing surgically tied knots or the use of the COR-KNOT® MIS DEVICE, COR-KNOT MINI® DEVICE, and COR-KNOT® QUICK LOAD® DEVICE or INTRA-KNOT® QUICK LOAD® as warranted by surgical circumstances and the experience of the surgeon.

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Marché principal en Pays-Bas ; disponible dans 32 pays au total.

Dénomination commerciale

SEW-EASY® 5.0mm COMBO KIT

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

00850200006490

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

0850200006SEW-EASY68

Numéro de référence/catalogue

022797

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The SEW-EASY® Device is a disposable single-use device, used in conjunction with removable single-use dual needle-carrying SEW-EASY® cassettes. The SEW-EASY® cassettes are attached to the SEW-EASY® DEVICE one at a time. The LSI SEW-EASY® Product Family Consists of the SEW-EASY® Device Kit containing a single device, Combo Kit that includes a device and 12 cassettes, and individually packaged Cassettes Singles. The Device and Combo Kits also include four valve handles with different connection types intended to be compatible with various valve models from different manufacturers.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• H9099SUTURE DEVICES - OTHER

• Dispositifs médicaux de Classe I dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.

Santé des certificats sur le portefeuille de ce fabricant.