BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 110041 · Received July 31, 1997

    Report

    Report Number
    1527736-1997-01869
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Report Date
    July 8, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EES# 974431-A. FACILITY EXPERIENCED AN EVENT WITH LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ON WHILE PERFORMING A UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 974431. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS, A-D NO ; DAMAGED JAWS, ABC-NO D-YES ; DAMAGED CUTTER, N/A ; DAMAGED FEED BAR, ABD-NO C-YES; DAMAGED FLOOR, A-D NO ; DAMAGED HANDLE SHROUDS, A-D NO ; DAMAGED OTHER, A-LOWER SHROUD; DAMAGED TIP SHROUDS, A-D NO ; DAMAGED TRIGGER, A-D NO ; DAMAGED TUBE, A-D NO ; DAMAGED WELD SEAMS, A-D NO . FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, ABD-YES C-N/A ; FIRING: FEED CONFORM, ABD-YES C-N/A ; FIRING: FORM CONFORM, B-YES ; JAWS: HOLD CLIP, AB-YES C-N/A D-NO ; JAWS: INSIDE WIDTH AT TIPS, A-.174 B-.173 C-.176 ; LOCKOUT FUNCTIONAL, ABD-YES C-N/A ; NUMBER OF CLIPS FED AND FORMED, B-7. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE A TOTAL OF FOUR INSTRUMENTS RETURNED. THE FIRST INSTRUMENT WAS RECEIVED WITH THE LOWER SHROUD DAMAGED. DUE TO THE DAMAGE TO THE INSTRUMENT, THE REMAINING CLIPS WERE FIRED NON CONFORMING. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE INSTRUMENT OCCURRED. THE SECOND INSTRUMENT FIRED THE REMAINING CLIPS AS DESIGNED WITH NO DIFFICULTIES NOTED. THE THIRD INSTRUMENT WAS RECEIVED EMPTY AND LOCKED OUT, THEREFORE, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE FOURTH INSTRUMENT WAS RECEIVED WITH THE JAWS DAMAGED. DUE TO THE DAMAGE TO THE INSTRUMENT, THE INSTRUMENT FIRED THE REMAINING CLIPS NON CONFORMING. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE INSTRUMENT OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, OR IF EXCESSIVE TORQUE IS APPLIED TO THE INSTRUMENT, THE INSTRUMENT CAN BECOME DAMAGED AND WILL NOT FORM THE CLIPS PROPERLY. 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 CONTINUOULSY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED (GAP). THERE WAS NO PT 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 J45M68

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other