BEUDAMED
    FDA Adverse Event Other Summary report: N

    FILSHIE CLIP APPLIER

    MDR report key: 859337 · Received May 29, 2007

    Report

    Report Number
    MW5002133
    Event Type
    Other
    Date Received
    May 29, 2007
    Date of Event
    May 18, 2007
    Report Date
    May 29, 2007
    Manufacturer
    AVALON MEDICAL CORP
    Product Code
    HGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING TUBAL STERILIZATION, THE FILSHIE CLIP APPLIER FAILED TO FIRE COMPLETELY. AFTER REMOVAL OF THE APPLIER FORM THE ABDOMINAL CAVITY, THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE SEPARATED AT ONE OF THE PRESSED STEAMS. PROCEDURE-TUBAL STERILIZATION- WAS ACCOMPLISHED VIA ON ALTERNATIVE METHOD, I.E., KLEPPINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIP APPLIER SURGICAL INSTRUMENT HGB AVALON MEDICAL CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other