BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC CLIP APPLIER

    MDR report key: 85004 · Received April 18, 1997

    Report

    Report Number
    1527736-1997-00664
    Event Type
    Malfunction
    Date Received
    April 18, 1997
    Report Date
    April 17, 1997
    Manufacturer
    EES-ALBUQUERQUE
    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

    FACILITY EXPERIENCED AN EVENT WITH YOUR LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER WHILE PERFORMING A UNKNOWN. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972233. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTONS & RESULTS: CLIP IN JAWS A-YES B-NO, DAMAGED JAWS AB-NO, DAMAGED CUTTER N/A, DAMAGED FEED BAR AB-NO, DAMAGED FLOOR AB-NO, DAMAGED HANDLE SHROUDS AB-NO, DAMAGED OTHER AN-NO, DAMAGED TIP SHROUDS A-NO B-YES, DAMAGED TRIGGER AB-NO, DAMAGED TUBE AB-NO, DAMAGED WELD SEAMS AB-NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL YES, FIRING: FEED CONFORM A-YES B-N/A, JAWS: HOLD CLIP A-YES B-N/A, JAWS: INSIDE WIDTH AT TIPS .172, LOCKOUT FUNCTIONAL A-YES B-N/A, NUMBER OF CLIPS FED AND FORMED A-12 B-0. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHEDAS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE FIRST INSTRUMENT CYCLED, FED AND FORMED THE REMAINING CLIPS AS DESIGNED. THE SECOND INSTRUMENT WAS RECEIVED EMPTY AND LOCKED OUT THEREFORE, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, IT WAS NOTED THAT THE SECOND INSTRUMENT WAS RECEIVED WITH THE LOWER SHROUD DAMAGED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DAMAGE TO THE INSTRUMENT. 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 THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED. THERE WAS PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO EES-ALBUQUERQUE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other