BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 93844 · Received May 23, 1997

    Report

    Report Number
    1527736-1997-01022
    Event Type
    Malfunction
    Date Received
    May 23, 1997
    Date of Event
    April 23, 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
    TX, 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 #972610. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECCHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS, DAMAGED JAWS, DAMAGE CUTTER, DAMAGED FEED BAR, DAMAGED FLOOR, DAMAGED HANDLE SHROUDS, DAMAGED OTHER, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS; NA. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, FIRING: FEED CONFORM, FIRING: FORM CONFORM, JAWS: HOLD CLIP, JAWS: INSIDE WIDTH AT TIPS, LOCKOUT FUNCTIONAL, AND NUMBER OF CLIPS FED AND FORMED; NA. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL INSPECTION OF THE CLIPS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE CLIPS TO MALFORM. AS THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION, IT COULD NOT BE ASCERTAINED AS TO WHY THE CLIPS MALFORMED. THE INSTRUMENT MUST BE FIRED UNTIL THE TRIGGER MEETS AND HANDLE TO ENSURE THE CLIP BEING APPLIED IS FULLY FORMED. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THE CLIPS WOULD NOT CLOSE COMPLETELY. THERE WAS NO CONSEQUENCE TO THE PT. REP IS SENDING BACK APPROX 8 CLIPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other