BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 155577 · Received March 9, 1998

    Report

    Report Number
    1527736-1998-00658
    Event Type
    Malfunction
    Date Received
    March 9, 1998
    Report Date
    February 9, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6; H2,3,4,6; G4: ADDED ADDITIONAL INFO. H6: ANVIL DISLODGED. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEALBE DAMAGED, NO; BATCH NUMBER, K01332; CARTRIDGE PAN IN PLACE/CONDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, FIRED AND POSITION/CONDITION OF WEDGE SLEDS, FULLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, GOOD; CONDITION OF CLAMPING MECHANISM, DAMAGED; CONDITION OF FIRING MECHANISM, GOOD; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGE BANDS, GOOD; IS HYPER LOCKOUT CONDITION PRESENT, GOOD AND RESULT OF ATTEMPTED FIRING, GOOD. ANALYSIS CONCLUSION: BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED WITH ANVIL DISLODGED FROM CLOSURE TUBE. WHEN THIS CONDITION EXISTS PRESSING RELEASE BUTTON WILL NOT OPEN INSTRUMENT. ANVIAL WAS RE-ALIGNED AND INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TSW35 WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED BY THE AFFILIATE THE INSTRUMENT WAS FIRED THREE TIMES WITHOUT INCIDENCE. THE DEVICE WAS RELOADED AND WOULD NOT FIRE FOR FOURTH FIRING. ANOTHER TSW35 WAS OPENED TO COMPLETE THE CASE. 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 K48114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other