BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC CONVERTER

    MDR report key: 35857 · Received August 22, 1996

    Report

    Report Number
    MW1009788
    Event Type
    Malfunction
    Date Received
    August 22, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 13, 1996
    Manufacturer
    RICHARD-ALLAN MEDICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLASTIC PIECES NOTED IN OPERATIVE FIELD USING DISPOSABLE CONVERTER. PIECES CONSISTENT WITH PORT VALVE BUT DEFECT IN PORT NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC CONVERTER DISPOSABLE CONVERTER GCJ RICHARD-ALLAN MEDICAL, INC. * H71117001X

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR