BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 84468 · Received April 16, 1997

    Report

    Report Number
    1527736-1997-00616
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 15, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: BENT CARTRIDGE LOCKOUT TABS. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ETS WHILE PERFORMING A THORACOSCOPY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971796. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K00T6U; CARTRIDGE PAN IN PLACE/CONDITION, AND CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, BENT; AND POSITION/CONDITOIN OF WEDGE SLEDS, FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, CONDITION OF CLAMPING MECHANISM, CONDITION OF FIRING MECHANISM, CONDITION OF KNIFE, AND CONDITION OF WEDGE BANDS, GOOD; AND IS HYPER LOCKOUT CONDITION PRESENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DID NOT CUT OR STAPLE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT,AND FORMED THE STAPLES WITHIN THE DESIGN SPECIFICATION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE RETURNED CARTRIDGE HAD BENT LOCKOUT TABS ON THE PAN, WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, STOPPED, THEN RESTARTED. WHEN THE FIRING CYCLE WAS RESTARTED, THE LOCKOUT TABS BECAME BENT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE TSW35 WAS USED DURING A THORASCOPIC BULLECTOMY. THE SURGEON REPORTED DIFFICULTY WHEN ATTEMPTING TO FIRE THE DEVICE (FIRST FIRING). WHEN THE DEVICE WAS REMOVED FROM THE TISSUE, IT HAD NOT CUT AND ONLY FOUR MALFORMED STAPLES WERE PRESENT. THERE WAS NO CONSEQUENCE TO THE PT. 3/21/97 ANOTHER TSW35 WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4675L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other