BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6177585 · Received December 15, 2016

    Report

    Report Number
    9612501-2016-01081
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    November 18, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES OPENED BY THE ACCOUNT. 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. THE VISUAL INSPECTION OF THE DEVICE LABELED ONE NOTED A BROKEN NEEDLE IN ONE OF THE NEEDLE RECEPTACLES. WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL SURROUNDING THE NEEDLE RECEPTACLE WERE NOTED ON THE OPPOSITE SIDE FROM THE BROKEN NEEDLE. THE HANDLE WAS BROKEN. THESE INVESTIGATION FINDINGS WERE ATTRIBUTED TO MISUSE OF THE PRODUCT. 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, THERE WAS NO INFORMATION AVAILABLE REGARDING THIS DEVICE. THERE WAS NO PATIENT INJURY OR HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829801 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6E1615X

    Patients

    Seq Age Sex Outcome Treatment
    1