BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 127006 · Received October 14, 1997

    Report

    Report Number
    1527736-1997-02623
    Event Type
    Malfunction
    Date Received
    October 14, 1997
    Date of Event
    August 12, 1997
    Report Date
    September 15, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTITIAL MEDWATCH, WAS SENT ON 10/14/97 WITHOUT AN DIRECT RESPONSE LETTER. ATTACHED IS THE RESPONSE. PRODUCT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, AB NO; BATCH NUMBER, A K01206 B EM00; CARTRIDGE PAN IN PLACE/CONDITION, A YES/GOOD N/A; CONDITION OF DRIVERS, A GOOD B N/A; LOCKOUT TABS ON PAN CONDITION, A BENT B N/A; POSITION/CONDITION OF WEDGE SLEDS, AB PARTIALLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, AB GOOD; CONDITION OF CLAMPING MECHANISM, AB GOOD; CONDITION OF FIRING MECHANISM, A GOOD; CONDITION OF KNIFE, AB GOOD; CONDITION OF WEDGE BANDS, A GOOD B N/A; IS HYPER LOCKOUT CONDITION PRESENT, AB NO AND RESULT OF ATTEMPTED FIRING, A GOOD B N/A. ANALYSIS CONCLUSION: BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT B(EZ35W) WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT A (WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENT A WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT INSTRUMENT A WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EXPERIENCE SURGEON REPORTED COULD NOT BE REPEATED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANSIM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC HYSTERECTOMY THE TSW35 STAPLERS DID NOT FIRE CORRECTLY. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other