BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6117798 · Received November 21, 2016

    Report

    Report Number
    9612501-2016-00940
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKETING VIGILANCE (PMV) RECEIVED ONE DEVICE, OPENED BY THE ACCOUNT WITHOUT THE APPROPRIATE PACKAGING. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. NO NEEDLE WAS RECEIVED WITH BOTH INSTRUMENTS. WITNESS MARKS ONE THE BEVEL WALL WAS OBSERVED FOR THE INSTRUMENT. THE INSTRUMENTS WAS LOADED WITH A NEEDLE FROM THE POST MARKETING VIGILANCE (PMV) INVENTORY AND APPLIED TO TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS FROM BOTH SIDES OF THE JAWS DURING THIS TEST IN AN EFFORT TO SIMULATE CLINICAL CONDITIONS. BOTH INSTRUMENTS WERE FOUND TO FUNCTION PROPERLY AND EACH NEEDLE REMAINED INTACT. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE FELL OUT OF THE STITCHING DEVICE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED WAS A LAPAROSCOPIC GASTRIC BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767925 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6H1745X

    Patients

    Seq Age Sex Outcome Treatment
    1