BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82239 · Received February 19, 1997

    Report

    Report Number
    1527736-1997-00167
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 19, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: CARTRIDE LOCKOUT DAMAGED, AS IF REFIRED AFTER FIRING. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COUD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, THE SURGEON FIRED THE TSW35 SIX TIMES WITHOUT DIFFICULTY. ON THE SEVENTH FIRING THE DEVICE MISFIRED. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW-UP: 1/24/97 1340 SURGEON DESCRIBED SEVERAL DIFFICULTIES WITH THE INSTRUMENT: SOMETIMES THE INSTRUMENT "UNLOCKED BEFORE FIRING," SOMETIMES IT WOULD NOT OPEN AFTER FIRING, AND IT FIRED STAPLES BUT DID NOT CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA J4500F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other