BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 105275 · Received July 9, 1997

    Report

    Report Number
    1527736-1997-01562
    Event Type
    Malfunction
    Date Received
    July 9, 1997
    Date of Event
    June 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED FIRING MECHANISM. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973674. 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, CRACKED; CONDITION OF FIRING MECHANISM, BROKEN; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGE BANDS, GOOD; IS HYPER LOCKOUT CONDITION PRESENT, NO AND RESULT OF ATTEMPTED FIRING, N/A. ANALYSIS CONCLUSION: BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT 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 MIGHT 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. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC SPLENECTOMY THE INSTRUMENT JAMMED ON THE TISSUE AFTER THE FIRST FIRING. THE JAWS WOULD NOT COME APART. THE SURGEON HAD TO PRY APART THE HANDLES TO RELEASE THE JAWS. ANOTHER TSW35 WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K46124

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other