BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 82176 · Received February 19, 1997

    Report

    Report Number
    1527736-1997-00171
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Report Date
    February 19, 1997
    Manufacturer
    EES ALBUQUERQUE
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: YIELDED JAWS. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. AS THE INSTRUMENT WAS RETURNED EMPTY, FURTHER FUNCTIONAL TESTING COULD BE PERFORMED. IT WAS NOTED THAT THE INSTRUMENT WAS RECEIVED WITH THE JAWS DAMAGED. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE JAWS OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT FORM THE CLIPS PROPERLY. 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

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE ER320 CLIPS WERE FALLING OUT. THERE WAS NO CONSEQUENCE TO THE PT. 1/27/97 THE CASE WAS COMPLETED WITH ANOTHER ER320. CLINICAL FOLLOW-UP: 1/29/97 1353 CONTACT PERSON STATED NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO EES ALBUQUERQUE NA J44N44

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other