BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 97639 · Received June 11, 1997

    Report

    Report Number
    1527736-1997-01225
    Event Type
    Malfunction
    Date Received
    June 11, 1997
    Report Date
    June 9, 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

    VISUAL INSPECTONS & RESULTS: CLIP IN JAWS AC-NO B-YES, DAMAGED JAWS AB-NO C-YES, DAMAGED CUTTER N/A, DAMAGED FEED BAR ABC-NO, DAMAGED FLOOR ABC-NO, DAMAGED HANDLE SHROUDS ABC-NO, DAMAGED TIP SHROUDS ABC-NO, DAMAGED TRIGGER AB-NO C-YES, DAMAGED TUBE ABC-NO, DAMAGED WELD SEAMS AC-YES B-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, LOCKOUT FUNCTIONAL AC-N/A B-YES. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE A TOTAL OF THREE INSTRUMENTS RETURNED. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED ON INST. A AS IT WAS RECEIVED EMPTY AND LOCKED OUT. INSTRUMENT B WAS RECEIVED WITH DAMAGE TO THE LOWER SHROUD. DUE TO THE DAMAGE TO THE INSTRUMENT, THE INSTRUMENT FIRED THE REMAINING CLIPS NON CONFORMING. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE INSTRUMENT OCCURRED. INSTRUMENT C WAS RECEIVED WITH DAMAGE TO THE TRIGGER, THE TOP SHROUD AND THE JAWS. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE INSTRUMENT OCCURRED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.

    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 (GAPS). 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 ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other