BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 87452 · Received April 24, 1997

    Report

    Report Number
    1527736-1997-00766
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    March 26, 1997
    Report Date
    April 23, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 #971998. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS YES, DAMAGED JAWS NO, DAMAGED CUTTER N/A, DAMAGED FEED BAR YES/BENT, DAMAGED FLOOR NO, DAMAGED HANDLE SHROUDS NO, DAMAGED OTHER N/A, DAMAGED TIP SHROUDS NO, DAMAGED TRIGGER NO, DAMAGED TUBE NO, DAMAGED WELD SEAMS NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL YES, FIRING: FEED CONFORM NO, FIRING: FORM CONFORM NO, JAWS: HOLD CLIP YES, JAWS: INSIDE WIDTH AT TIPS .178, LOCKOUT FUNCTIONAL YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE FEEDBAR HAD BECOME DAMAGED AND WOULD NOT FORM THE CLIPS PROPERLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE FEEDBAR OCCURRED. 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 ER320 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS SPITTING CLIPS AND NOT CLOSING PROPERLY. THE CLIPS WERE RETRIEVED. A SECOND DEVICE WAS OPENED AND THE SAME THING HAPPENED BEFORE IT WAS PUT INTO THE BODY (THE REP IS RETURNING THIS DEVICE). A THIRD ER320 WAS PULLED TO COMPLETE THE CASE AND WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT.

    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 J45615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other