BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 84510 · Received April 16, 1997

    Report

    Report Number
    1527736-1997-00605
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 15, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION; A NA B BROKEN. CARTRIDGE CONDITION; A NA B 10 STAPLES F. CARTRIDGE RETURN BATCH NUMBER; A NA B EM0158. INSTRUMENT NUMBER; A 0060 B 0350. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT; AB GOOD. CONDITION OF PINION GEAR; AB GOOD. CONDITION OF SHORT RACK; AB GOOD. CONDITION OF YOKE; AB GOOD. TEST CARTRIDGE BATCH #; AB NA. WAS INSTRUMENT CYCLED; AB GOOD. ANLAYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUCTIONS WERE RETURNED NON-FUNCTIONAL. THE INSTRUMENTS WERE DISASSEMBLED AND WERE FOUND TO HAVE DAMAGED FIRING MECHANISMS. CARTRIDGE B WAS RETURNED WITH THE MIDDLE ALIGNMENT FINGER AND LOCKOUT TAB BROKEN OFF AND MISSING. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.

    Description of Event or Problem · 1

    THE INSTRUMENTS WERE USED DURING A LAPAROSCOPIC PELVIC OOPHERECTOMY. IT WAS REPORTED ON THE FIRST FIRING OF THE STAPLER IT DID NOT CUT. THE STAPLER WAS RELOADED AND STILL WOULD NOT CUT. A NEW INSTRUMENT WAS OPENED AND THE HANDLE BROKE UPON FIRING. ANOTHER INSTRUMENT WAS OPENED THAT WORKED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J43R6A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other