BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 131145 · Received November 7, 1997

    Report

    Report Number
    1527736-1997-02912
    Event Type
    Malfunction
    Date Received
    November 7, 1997
    Date of Event
    September 30, 1997
    Report Date
    October 10, 1997
    Manufacturer
    LACEY MANUFACTURING CO.
    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

    H6; IT WAS CONCLUDED THAT DRIED BODY FLUIDS HAD BONDED THE FEEDBAR TO THE APPLIER FLOOR, BUT NO CONCLUSION COULD BE REACHED ON HOW THE INSTRUMENT BROKE INTO PIECES. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS; BODY ASSEMBLY BOWED, A)DISASSEMBLED B); CLIP IN JAW, AB)NO; CLIP STACK PRESSURE, A)POOR B)GOOD; CLIP STAGING, A)POOR B)GOOD; CLIP TRACK LOCATION, A)POOR B)GOOD; CONDITION OF CARTRIDGE COVER TABS, A)SHEARED FORWARD AND TOTAL # CLIPS REMAINING, A)13 B)12. FUNCTIONAL TESTS & RESULTS: ANTI-BACKUP FUNCTIONAL, A)N/A B)YES; CLIP FORM PROPERLY, A)N/A B)YES; CLIP FEED PROPERLY, A)N/A B)YES; CYCLE APPLIER, A)NO/UNABLE B)YES AND LOCKOUT FUNCTIONAL, AB)N/A. ANALYSIS CONCLUSION: AB)IT WAS CONCLUDED THAT REPORTED INCIDENT DURING SURGERY MAY HAVE BEEN DUE TO; A)DRIED BODY FLUIDS ADHERING FEEDBAR TO APPLIER FLOOR. APPLIER WAS RECEIVED DISASSEMBLED (MISSING PAWL AND LOOP SPRING), WITH TRACK ASSEMBLY SHEARED FORWARD, AND WITH NO CLIP IN JAWS. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO APPLIER'S PHYSICAL CONDITION. B)CARTRIDGE COVER SEPARATING FROM APPLIER BODY. APPLIER WAS RECEIVED WITH NO CLIP IN JAWS AND WITH BODY BOWED ON RIGHT SIDE. APPLIER WAS CYCLED AND PROPERLY FED A CLIP INTO JAWS, AND THEN FIRED AND PROPERLY FORMED 5 CLIPS WITHIN DESIGN SPECIFICATION AND THEN STOPPED ADVANCING CLIPS BECAUSE PUSHER SPRING WENT PASSED REAR TAB OF CLIP TRACK DUE TO EXCESSIVE CLEARANCE CAUSED BY BOWED BODY. NO CONCLUSION COULD BE REACHED ON HOW BODY HAD BECOME BOWED. AB)EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. A)BRIEFLY SWISHING APPLIER WITH SALINE BETWEEN USES WILL REDUCE OCCURRENCE OF THIS INCIDENT. B)THE APPLIER BODY MAY BECOME BOWED IF PRESSURE IS APPLIED TO FRONT OF SHAFT ASSEMBLY AND A TORQUING MOTION IS APPLIED TO HANDLES, WHICH MAY CAUSE BODY ASSEMBLY TO BOW OR FLEX OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A FEMOROPOPLITEAL BYPASS PROCEDURE. IT WAS REPORTED THE MCL20 JAMMED AND BROKE INTO PIECES. A SECOND MCL20 WOULD NOT RELEASE THE CLIP AND WAS STUCK IN THE JAWS OF THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER GDO LACEY MANUFACTURING CO. NA K46J2L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other