BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 118989 · Received September 11, 1997

    Report

    Report Number
    1527736-1997-02279
    Event Type
    Malfunction
    Date Received
    September 11, 1997
    Date of Event
    August 13, 1997
    Report Date
    August 13, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED CLOSURE MECHANISM. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE NO, BATCH NUMBER K01075, CARTRIDGE PAN IN PLACE/CONDITION GOOD, CONDITION OF DRIVERS GOOD, LOCKOUT TABS ON PAN CONDITION BENT, POSITION/CONDITION OF WEDGE SLEDS PARTIALLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT GOOD, CONDITION OF CLAMPING MECHANISM BROKEN, CONDITION OF FIRING MECHANISM GOOD, CONDITION OF KNIFE GOOD, CONDITION OF WEDGE BAND GOOD, IS HYPER LOCKOUT CONDITION PRESENT NO. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED CLOSURE MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE RETURNED CARTRIDGE HAD A BENT LOCKOUT TAB ON THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, THE LOCKOUT TAB ON THE CARTRIDGE BECAME DAMAGED. IF THE INSTRUMENT'S FIRING CYCLE IS INTERRUPTED, RELEASED, THEN RESTARTED, THE CARTRIDGE WILL LOCKOUT AND A NEW CARTRIDGE SHOULD BE LOADED INTO THE INSTRUMENT. 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 PRODUCTS.

    Description of Event or Problem · 1

    THE ATW35 WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE DEVICE WOULD NOT FIRE ON THE FIRST FIRING. THE DEVICE WAS THEN RELOADED AND WORKED FINE FOR A FEW MORE FIRINGS. ON THE FIFITH FIRING THE DEVICE WOULD NOT FIRE. A NEW 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 FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K47D9V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other