BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE

    MDR report key: 1061339 · Received June 16, 2008

    Report

    Report Number
    MW5007313
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 16, 2008
    Manufacturer
    COVIDEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OR UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY; WHEN CLIPS FIRED, TIPS CROSSED AND DID NOT HOLD; DEFECTIVE CLIPS REMOVED BY SURGEON; PATIENT DID WELL POSTOPERATIVELY AND WAS DISCHARGED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP LARGE 10MM GDO COVIDEN 176625

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR