BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 86049 · Received April 17, 1997

    Report

    Report Number
    1527736-1997-00659
    Event Type
    Malfunction
    Date Received
    April 17, 1997
    Report Date
    April 17, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    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 #972234. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS ABC-NO, DAMAGED JAWS ABC-NO, DAMAGED CUTTER N/A, DAMAGED FEED BAR ABC-NO, DAMAGED FLOOR A-YES BC-NO, DAMAGED HANDLE SHROUDS ABC-NO, DAMAGED OTHER N/A, DAMAGED TIP SHROUDS AB-YES LOWER SHROU, DAMAGED TRIGGER ABC-NO, DAMAGED TUBE ABC-NO, DAMAGED WELD SEAMS ABC-NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL AC-N/A B-YES, FIRING: FEED CONFORM AC-N/A B-YES, FIRING: FORM CONFORM AC-N/A B-NO, JAWS: HOLD CLIP AC-N/A B-YES, JAWS: INSIDE WIDTH AT TIPS A-.182 B-0167 C-0174, LOCKOUT FUNCTIONAL AC-N/A B-YES. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISULA AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. BOTH OF THE RETURNED INSTRUMENTS WERE RECEIVED WITH DAMAGE TO THE LOWER SHROUD OF THE INSTRUMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE INSTRUMENTS OCCURRED. AS INTRUMENT A WAS RETURNED EMPTY AND LOCKED OUT, FURTHER FUNCTIONAL TESTING COULD NOT BE PEFORMED. INSTRUMENT B WAS RETURNED THE LOWER SHROUD DAMAGED AND WOULD NOT FORM THE CLIPS PROPERLY. NO CONCLUSION COULD BE REACHEC AS TO HOW THE DAMAGE TO THE INSTRUMENT OCCURRED. ON 6/2/97, AN ADDITIONAL INSTRUMENT WAS RECEIVED FOR THIS PRODUCT INQUIRY. THE INSTRUMENT WAS RECIEVED EMPTY AND LOCKED OUT, THEREFORE, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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 AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other