BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82855 · Received April 3, 1997

    Report

    Report Number
    1527736-1997-00478
    Event Type
    Malfunction
    Date Received
    April 3, 1997
    Date of Event
    March 3, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR 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 #971450. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE; AB NO. BATCH #; A J00H67 B J00H4. CARTRIDGE PAN IN PLACE/CONDITION; AB YES. CONDITION OF DRIVERS, AND LOCKOUT TABS ON PAN CONDITION; AB GOOD. POSITION/CONDITION OF WEDGE SLEDS; AB 1/4 FIRED/BENT. 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. IS HYPER LOCKOUT CONDITION PRESENT; NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "LOCKED OUT" DURING SURGERY. THE RETURNED CARTRIDGES HAD BENT PAN LOCKOUT TABS WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, STOPPED, THEN RESTARTED. THIS CAUSED THE CARTRIDGE TABS TO BECOME BENT IN THE LOCKED POSITION. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN 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. 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

    DURING A THORACOSCOPIC LOBECTOMY THE TSW35 LOCKED OUT WHEN A SECOND RELOAD WAS PLACED IN THE DEVICE. A THIRD RELOAD WAS PLACE IN THE DEVICE AND IT ALSO LOCKED OUT. AN ATW35 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4616K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other