BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 84997 · Received April 18, 1997

    Report

    Report Number
    1527736-1997-00665
    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 INSPECTIONS & 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, DAMAPED 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, FIRING: FORM CONFORM A-YES B-N/A, JAWS: HOLD CLIP A-YES B-N/A, LOCKOUT FUNCTIONAL A-YES B-N/A, NUMBER OF CLIPS FED AND FORMED A-12 B-0. ANALYSIS CONCLUSION: BSED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS 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 TESTING COULD NOT BE PERFORMED. HOWEVER, IT WAS NOTED 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 ORDCER TO CONTINUOULSY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICES WERE USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED. 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 EES-ALBUQUERQUE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other