BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 93848 · Received May 23, 1997

    Report

    Report Number
    1527736-1997-01020
    Event Type
    Malfunction
    Date Received
    May 23, 1997
    Date of Event
    January 10, 1997
    Report Date
    May 23, 1997
    Manufacturer
    EES ALBUQUERQUE
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RETURNED TO CO WITH PRODUCT INQUIRY #972603. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS; A-YES B-NO. DAMAGED JAWS, DAMAGED FEED BAR, DAMAGED FLOOR, DAMAGED HANDLE SHROUDS, DAMAGED OTHER, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS; AB-NO. DAMAGED CUTTER; NA. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTION, FIRING: FEED CONFORM, FIRING: FORM CONFORM, JAWS: HOLD CLIP, LOCKOUT FUNCTIONAL, AND NUMBER OF CLIPS FED AND FORMED; NA. JAWS: INSIDE WIDTH AT TIPS; A-.170 B-.175. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENTS WERE RETURNED EMPTY AND LOCKED OUT. NO TESTING COULD BE PERFORMED AS THE INSTRUMENTS WERE RETURNED EMPTY. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. 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 ORDRE TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE ER320 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS FROM THE ER320 OVERLAPPED. THERE IS NO OTHER INFO AVAILABLE. ANOTHER OPENED AND THE SAME THING HAPPENED. A THIRD DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO EES ALBUQUERQUE NA J45C7Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other