BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 86286 · Received April 21, 1997

    Report

    Report Number
    1527736-1997-00703
    Event Type
    Malfunction
    Date Received
    April 21, 1997
    Date of Event
    March 24, 1997
    Report Date
    April 21, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER WHILE PERFORMING A LAP CHOLECYSTECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971858. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS NO, DAMAGED JAWS NO, DAMAGED CUTTER N/A, DAMAGED FEED BAR NO, DAMAGED FLOOR NO, DAMAGED HANDLE SHROUDS NO, DAMAGED OTHER NO, DAMAGED TIP SHROUDS NO, DAMGED TRIGGER NO, DAMAGED TUBE NO, DAMAGED WELD SEAMS NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL YES, FIRING: FEED CONFORM YES, FIRING: FORM CONFORM YES, JAWS: HOLD CLIP YES, JAWS: INSIDE WIDTH AT TIPS .195, LOCKOUT FUNCTIONAL YES, NUMBER OF CLIPS FED AND FORMED 10. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTGRUMENT FED, FIRED AND FORMED THE REMAINING CLIPS AS DESIGNED. THE REPORTED INCIDENT COULD NOT BE RECREATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A GALL BLADDER PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS ARE MALFORMED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J4239A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other