BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 100950 · Received June 25, 1997

    Report

    Report Number
    1527736-1997-01412
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Date of Event
    April 17, 1997
    Report Date
    June 24, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973302. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, J00N56; CARTRIDGE PAN IN PLACE/CONDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, BENT AND POSITION/CONDITION OF WEDGE SLEDS, PARTIALLY 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 INQUIRY INFO RECEIVED, VISUAL EXAMINATION, AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY INSTRUMENT REPORTEDLY "WOULD NOT ADVANCE" DURING SURGERY. INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. IT WAS CONCLUDED THAT INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EXPERIENCE SURGEON REPORTED COULD NOT BE REPEATED. RETURNED CARTRIDGE HAD A BENT LOCKOUT TAB ON PAN WHICH INDICATES THAT INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, LOCKOUT TAB ON CARTRIDGE BECAME DAMAGED. IF INSTRUMENT'S FIRING CYCLE IS INTERRUPTED, RELEASED, THEN RESTARTED, CARTRIDGE WILL LOCKOUT AND A NEW CARTRIDGE SHOULD BE LOADED INTO INSTRUMENT. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE 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 AND RELOADED THE DEVICE. ON THE SECOND FIRING, THE FIRING HANDLE WOULD NOT ADVANCE TO FIRE THE DEVICE. A SECOND ATW35 WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA J45J6P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R