BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 91236 · Received May 13, 1997

    Report

    Report Number
    1527736-1997-00918
    Event Type
    Malfunction
    Date Received
    May 13, 1997
    Report Date
    May 12, 1997
    Manufacturer
    LACEY MANUFACTURING CO.
    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

    DEVICE #2: H6; DAMAGED ANTI-BACKUP. PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BODY ASSEMBLY BOWED, AB)NO; CLIP IN JAW, A)NO B)YES; CLIP STACK PRESSURE, AB)GOOD; CLIP STAGING, A)N/A B)GOOD; CLIP TRACK LOCATION, AB)GOOD; CONDITION OF CARTRIDGE COVER TABS, AB)GOOD AND TOTAL # CLIPS REMAINING, A)0 B)7. FUNCTIONAL TESTS & RESULTS: ANTI-BACKUP FUNCTIONAL, A)N/A B)NO/STRIPPED; CLIPS FORM PROPERLY, A)N/A B)YES; CLIP FEED PROPERLY, A)N/A B)YES; CYCLE APPLIER, A)NO B)YES AND LOCKOUT FUNCTIONAL, AB)YES. ANALYSIS CONCLUSION: AB)BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST; A)NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT DURING SURGERY. APPLIER WAS RECEIVED EMPTY AND LOCKED OUT AND NO FUNCTIONAL TESTING COULD BE PERFORMED. APPLIER WAS EXAMINED AND WAS FOUND TO BE WITHIN DESIGN SPECIFICATIONS. B)IT WAS CONCLUDED THAT REPORTED INCIDENT MAY HAVE BEEN CAUSED BY STRIPPED PAWL. APPLIER WAS CYCLED, AND PAWL WAS OBSERVED TO BE STRIPPED, BUT FIRED AND PROPERLY FORMED REMAINING 7 CLIPS. NO CONCLUSION COULD BE REACHED AS TO HOW PAWL HAD BECOME STRIPPED. A)EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. B)IF FIRING HANDLES ARE FORCED OPEN BEFORE FIRING STROKE IS COMPLETED, PAWL WILL BECOME STRIPPED. INSTRUMENT MUST BE FIRED UNTIL HANDLES MEET BODY ASSEMBLY TO ENSURE CLIPS BEING APPLIED IS FULLY FORMED. AFTER FIRING STROKE IS COMPLETED, HANDLES WILL RETURN TO OPEN POSITION.

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS DID NOT CLOSE WITH ENOUGH PRESSURE TO AVOID THE BLOOD FLUX. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER GDO LACEY MANUFACTURING CO. NA K46221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other