BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP RIGHT ANGLE MULTIPLE CLIP APPLIER

    MDR report key: 218766 · Received April 12, 1999

    Report

    Report Number
    1527736-1999-02088
    Event Type
    Malfunction
    Date Received
    April 12, 1999
    Date of Event
    March 15, 1999
    Report Date
    March 18, 1999
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT THE CLIPS OF THE RA320 WERE CROOKED. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP RIGHT ANGLE MULTIPLE CLIP APPLIER CLIP APPLIER GDO ORIGIN MEDSYSTEMS, INC. NA L4CO51

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other