BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE LAPAROSCOPIC

    MDR report key: 1697506 · Received May 19, 2010

    Report

    Report Number
    MW5016041
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 19, 2010
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, 11:09 AM (B) (6), END OF DISPOSABLE LAPAROSCOPIC CLIP APPLIER BROKE OFF INTO PT. BROKEN PIECE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LAPAROSCOPIC GASTROENTEROLOGY PRODUCTS FZP APPLIED MEDICAL REF CA090 10MM 1108836

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR