BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 98207 · Received June 12, 1997

    Report

    Report Number
    1527736-1997-01267
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    March 21, 1997
    Report Date
    June 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: YIELDED JAWS. FACILITY EXPERIENCED AN EVENT WITH LIGACLIP* ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ON 3/21/97 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 #973510. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW, NO; DAMAGED JAWS, NO; DAMAGED FEED BAR, NO; DAMAGED HANDLE SHROUDS, NO; DAMAGED TIP SHROUDS, NO; DAMAGED TRIGGER, NO; DAMAGED TUBE, NO AND DAMAGED WELD SEAMS, NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, YES; FIRING: FEED CONFORM, YES; FIRING: FORM CONFORM NO; JAWS: HOLD CLIP, YES; LOCKOUT FUNCTIONAL, N/A AND NUMBER OF CLIPS FED AND FORMED, 2 SCISSORED. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH MISALIGNED JAW TIPS. THE INSTRUMENT WAS CYLCED AND SCISSORED THE CLIPS DUE TO THE MISALINGED JAW TIPS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE 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 CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS WERE MALFORMED (SCISSORED). A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J44Y1D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other