BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 116837 · Received August 28, 1997

    Report

    Report Number
    1527736-1997-02167
    Event Type
    Malfunction
    Date Received
    August 28, 1997
    Date of Event
    July 30, 1997
    Report Date
    August 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS, DAMAGED FEED BAR, DAMAGED FLOOR, DAMAGED HANDLE SHROUDS, DAMAGED OTHER, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS, NO; DAMAGED JAWS, YES/TWISTED; AND DAMAGED CUTTER, NA. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, AND LOCKOUT FUNCTIONAL, YES; FIRING: FEED AND FORM, JAWS: HOLD CLIP, NO; AND JAWS: INSIDE WIDTH AT TIPS, .176. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND WOULD NOT HOLD OR FORM THE CLIPS PROPERLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE JAWS OCCURRED. IF THE JAWS ARE TORQUED OR 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.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE USING AN ER220 A CLIP SHOT OUT OF THE DEVICE. THE JAWS THEN CUT ADIPOSE TISSUE WHEN CLOSED. NO VESSEL WAS CUT. THE SURGEON FIRED CLIPS OVER THE MAYO STAND TO CHECK CLIP FORMATION. THE CLIPS DID NOT FORM CORRECTLY. AFTER THE CASE, THE SURGEON DRY FIRED THE ER220 AND GOOD CLIP FORMATION WAS NOTED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA K46Z2L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other