BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER

    MDR report key: 175764 · Received July 2, 1998

    Report

    Report Number
    1527736-1998-01908
    Event Type
    Malfunction
    Date Received
    July 2, 1998
    Date of Event
    June 1, 1998
    Report Date
    June 5, 1998
    Manufacturer
    POST SURGICAL MFG
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT THE EL314 CLIP APPLIER WOULD NOT HOLD THE CLIP. ANOTHER EL314 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. NO DR NAME AVAILABLE DUE TO INSTRUMENT BEING LEFT IN CSR ACCORDING TO REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER CLIP APPLIER GDO POST SURGICAL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other