BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE LAPAROSCOPIC CLIP APPLIER

    MDR report key: 32524 · Received May 2, 1996

    Report

    Report Number
    MW1009010
    Event Type
    Malfunction
    Date Received
    May 2, 1996
    Date of Event
    April 11, 1996
    Report Date
    April 17, 1996
    Manufacturer
    RICHARD-ALLAN MEDICAL INDUSTRIES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC CLIP APPLIER FAILED TO RELOAD AND APPLY CLIP ON CYSTIC ARTERY. FURTHER FORCE APPLIED. APPLIER DID NOT LOAD CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE LAPAROSCOPIC CLIP APPLIER CLIP APPLIER GDO RICHARD-ALLAN MEDICAL INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR