BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 109648 · Received July 30, 1997

    Report

    Report Number
    1527736-1997-01840
    Event Type
    Malfunction
    Date Received
    July 30, 1997
    Date of Event
    June 6, 1997
    Report Date
    July 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EES# 974110-C. H6; CODE 400: BROKEN TOWERS. FACILITY EXPERIENCED AN EVENT WITH ENDOPATH ETS 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 # 974110. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, A BROKEN TOWERS B ; CARTRIDGE PAN IN PLACE/CONDITION, AB YES/GOOD ; CONDITION OF DRIVERS, AB GOOD ; LOCKOUT TABS ON PAN CONDITION, AB FIRED AND POSITION/CONDITION OF WEDGE SLEDS, A PARTIALLY FIRED/SP. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, N/A ; CONDITION OF CLAMPING MECHAMISM, N/A ; CONDITION OF FIRING MECHANISM, N/A ; CONDITION OF KNIFE, N/A ; CONDITION OF WEDGE BANDS, N/A ; IS HYPER LOCKOUT CONDITION PRESENT, N/A AND RESULT OF ATTEMPTED FIRING, N/A . ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION IT WAS CONCLUDED THAT CARTRIDGE A WAS RETURNED WITH A SPLIT WEDGE SLED AND WITH BROKEN TOWERS. NO CONCLUSION COULD BE REAHCED AS TO HOW THIS DAMAGE OCCURRED. CARTRIDGE B WAS RETURNED FULLY FIRED AND IN GOOD PHYSICAL CONDITION. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE CARTRIDGES RETURNED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. IT WAS REPORTED THE SURGEON FIRED THE ATW35 TWICE ON THE LEFT SIDE OF THE UTERUS. DURING THE THIRD FIRING AT THE LEVEL OF THE ROUND LIGAMENT TOWARD THE BROAD LIGAMENT THE STAPLER WAS FULLY ARTICULATED. THE STAPLES ON THE RIGHT SIDE STAPLED, BUT THE STAPLES ON THE LEFT SIDE OF THE CUT LINE HAD INCONSISTENTLY FORMED AND THERE WAS STAPLE LINE BLEEDING. THE SURGEON USED LIGACLIPS TO CONTROL THE BLEEDING. THE SURGEON CONTINUED TO USE THE DEVICE AND EXPERIENCE THE SAME DIFFICULTY ON THE FIFTH FIRING. THE SURGEON COMPLETED THE PROCEDURE WITH THIS DEVICE. THE SALES REP DOES NOT HAVE THE DEVICE. BUT IS RETURNING THE TWO RELOADS THAT EXPERIENCED THE DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K46N2F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other