BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 100953 · Received June 25, 1997

    Report

    Report Number
    1527736-1997-01438
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Date of Event
    February 24, 1997
    Report Date
    June 25, 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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM. FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* EST ON 2/24/97 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 #973652. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, BROKEN TOWERS; BATCH NUMBER, K00R6V; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, BENT AND POSITION/CONDITION OF WEDGE SLEDS, 2/3 FIRED. 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 AND IS HYPER LOCKOUT CONDITION PRESENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH SLIGHT HANDLE SEAM SEPARATION, BROKEN TRIGGER TEETH, AND A BROKEN HANDLE SHROUD TRIGGER POST. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE INSTRUMENT RETURNED. THE RETURNED CARTRIDGE HAD BROKEN TOWERS AND A BENT LOCKOUT TAB ON THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, THE LOCKOUT TAB ON THE CARTRIDGE BECAME DAMAGES. IF THE INSTRUEMNT'S FIRING CYCLE IS INTERRUPTED, RELEASED, THEN RESTARTED, THE CARTRIDGE WILL LOCKOUT AND A NEW CARTRIDGE SHOULD BE LOADED INTO THE INSTRUMENT. 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 CO'S 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 TSW35 MISFIRED. A NEW TSW35 WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE DEVICE WAS JUST RELEASED BY THE HOSPITAL'S RISK MGMT DEPT. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4621N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other