BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH LINEAR CUTTERS

    MDR report key: 103387 · Received July 2, 1997

    Report

    Report Number
    1527736-1997-01508
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Date of Event
    June 3, 1997
    Report Date
    July 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973669. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K00V45; CARTIDGE PAN IN PLACE/CONDITION, GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, BENT AND POSITION/CONDITION OF WEDGE SLEDS, FULLY 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; IS HYPER LOCKOUT CONDITION PRESENT, NO AND RESULT OF ATTEMPTED FIRING, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE RETURNED CARTRIDGE HAD 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 DAMAGED. IF THE INSTRUMENT'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 OCCURES IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY THE INSTRUMENT STUCK IN THE TISSUE. THE SURGEON ATTEMPTED TO FIRE THE TSB35 TWICE. ANOTHER TSB35 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH LINEAR CUTTERS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4B02P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other