BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC/COVIDIEN ENDOSTITCH DEVICE

    MDR report key: 12107991 · Received July 1, 2021

    Report

    Report Number
    MW5102261
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    March 22, 2021
    Report Date
    June 28, 2021
    Manufacturer
    MEDTRONIC/COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ENDO STITCH AND V-LOC 180 DURING A LAVH THE NEEDLE BROKE. IT WAS SEEN ON X-RAY BUT THE PIECE WAS UNABLE TO BE LOCATED AND RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994509 MEDTRONIC/COVIDIEN ENDOSTITCH DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW MEDTRONIC/COVIDIEN J9L0758EY
    994525 V-LOC180 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM MEDTRONIC/COVIDIEN N1A0958Y

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other