BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 90357 · Received May 8, 1997

    Report

    Report Number
    1527736-1997-00871
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    April 9, 1997
    Report Date
    May 8, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: BENT CARTRIDGE TAB. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ETS FLEX WHILE PERFORMING A L.A.V.H.. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972184. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. FUNCTIONAL TESTS & RESULTS: ARTICULATION FUNCTION, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE CARTRIDGE REPORTEDLY "JAMMED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. 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 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. 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 ATW35 WAS USED DURING AN LAVH. ON THE FOURTH FIRING THE CARTRIDGE JAMMED. THE DEVICE COULD HAVE BEEN PARTIALLY FIRED BECAUSE STAPLES WERE SEEN AT THE PROXIMAL PART OF THE TISSUE. A NEW CARTRIDGE WAS LOADED AND THE DEVICE WAS FIRED, BUT IT WAS DIFFICULT TO FIRE. THE FIRING DID OCCUR OVER PREVIOUS STAPLES. 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 K46H77

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other