BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 91232 · Received May 13, 1997

    Report

    Report Number
    1527736-1997-00917
    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 #1. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE INGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS AND 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 AND RESULTS: ANTI-BACKUP FUNCTIONAL, A) N/A B) NO/STRIPPED; CLIP 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 THE INQUIRY INFORMATION RECIEVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST; A) NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. THE APPLIER WAS RECEIVED EMPTY AND LOCKED OUT AND NO FUNCTIONAL TESTING COULD BE PERFORMED. THE APPLIER WAS EXAMINED AND WAS FOUND TO BE WITIN DESIGN SPECIFICATIONS. B) IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY A STRIPPED PAWL. THE APPLIER WAS CYCLED, AND THE PAWL WAS OBSERVED TO BE STRIPPED, BUT FIRED AND PROPERLY FORMED THE REMAINING 7 CLIPS. NO CONCLUSION COULD BE REACHED AS TO HOW THE PAWL HAD BECOME STRIPPED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCEES TO ENSURE THAT IT FUNCTIONS PROPERLY.

    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