BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 105267 · Received July 9, 1997

    Report

    Report Number
    1527736-1997-01571
    Event Type
    Malfunction
    Date Received
    July 9, 1997
    Date of Event
    June 6, 1997
    Report Date
    July 8, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973991. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, N/A; BATCH NUMBER, N/A; CARTIDGE PAN IN PLACE/CONDITION, N/A; CONDITION OF DRIVERS, N/A; LOCKOUT TABS ON PAN CONDITION, N/A AND POSITION/CONDITION OF WEDGE SLEDS, N/A. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, GOOD; CONDITION OF CLAMPING MECHANISM, GOOD; CONDITION OF FIRING MECHANISM, GOOD; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGE BANDS, GOOD; IS HYPER LOCKOUT CONDITION PRESENT, NO AND RESULT OF ATTEMPTED FIRING, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. 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 OUR PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE DEVICE WAS PLACED ON THE TISSUE, LOCKED INTO PLACE, AND THEN IT WOULD NOT FIRE. TWO ADDITIONAL RELOADS WERE PLACED IN THE INSTRUMENT AND THE GUN WOULD NOT FIRE. A NEW INSTRUMENT WAS OPENED AND IT WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT. 6/27/97 REP REPORTED THIS OCCURRED ON THE INITIAL FIRING, THEN THE TWO ADD'L RELOADS WERE TRIED. ONLY THE INSTRUMENT WITH ONE CARTRIDGE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K46V3L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other