BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 154087 · Received March 4, 1998

    Report

    Report Number
    1527736-1998-00594
    Event Type
    Malfunction
    Date Received
    March 4, 1998
    Date of Event
    February 3, 1998
    Report Date
    February 4, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE-A: D5; H2,3,4,6; G4: ADDED ADD'L INFO. H6; ANVIL DISLODGED. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, A NO B BROKEN TOW; BATCH NUMBER, A K01880 B K017; CARTIDGE PAN IN PLACE/CONDITION, AB YES/GOOD; CONDITION OF DRIVERS, AB GOOD; LOCKOUT TABS ON PAN CONDITION, A BENT B FIRED AND POSITION/CONDITION OF WEDGE SLEDS, A FULLY FIRED B PARTIALLY. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, AB GOOD; CONDITION OF CLAMPING MECHANISM, AB GOOD; CONDITION OF FIRING MECHANISM, A GOOD B BENT; CONDITION OF KNIFE, AB GOOD; CONDITION OF WEDGE BANDS, AB GOOD AND IS HYPER LOCKOUT CONDITION PRESENT, AB NO. ANALYSIS CONCLUSION: BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT A WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENT A 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 INSTRUMENT B WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGH RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY THE SURGEON FIRED THE TSW35 FIVE TIMES ACROSS THE ROUND AND BROAD LIGAMENTS. AFTER THE 6TH FIRING THE DEVICE HANDLES LOCKED TOGETHER AND WOULD NOT OPEN AND ACCEPT ANOTHER RELOAD. A 2ND TSW35 WAS OPENED. ON THE 1ST FIRING A LOUD CRACKING NOISE WAS HEARD. THE STAPLE LINE FIRED FINE, BUT THE DEVICE WAS THEN UNFUNCITONAL. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K48M6N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other