BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOLF

    MDR report key: 226158 · Received June 7, 1999

    Report

    Report Number
    226158
    Event Type
    Other
    Date Received
    June 7, 1999
    Date of Event
    May 27, 1999
    Report Date
    June 7, 1999
    Manufacturer
    MEDICAL INSTRUMENT CORP
    Product Code
    HGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY THE HULKA CLIP CAME OFF THE APPLIER INTO THE PATIENT'S ABDOMEN. DURING ATTEMPTS TO RETRIEVE THE CLIP IT CAME APART IN TWO PIECES. THE GOLD METAL PIECE WAS RETRIEVED, BUT ALL ATTEMPTS TO RETRIEVE THE PLASTIC PIECE FAILED. THE MISSING PIECE COULD NOT BE LOCATED BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLF Implant HULKA CLIP HGB MEDICAL INSTRUMENT CORP * 1273

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other ULTRASOUND 6/2/99.