BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82245 · Received February 19, 1997

    Report

    Report Number
    1527736-1997-00162
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    January 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: BROKEN PISTON GEAR/APPEARS THAT FIRING STROKE WAS STARTED, RELEASED, THEN RESTARTED. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE RETURNED CARTRIDGE HAD BENT LOCKOUT TABS ON THE PAN WHICH INDICATE THE FIRING CYCLE WAS STOPPED, RELEASED, THENR RESTARTED. THE INSTRUMENT WAS RETURNED WITH A BROKEN PINION GEAR. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE INSTRUMENT RETURNED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED.

    Description of Event or Problem · 1

    DURING A LAPAROSOCPIC ASSISTED VAGINAL HYSTERECTOMY THE SURGEON COULD NOT FIRE THE TSB35. THERE WAS NO CONSEQUENCE TO THE PT. 1/27/97 ANOTHER TSB WAS USED TO COMPLETE THE CASE. CLINICAL FOLLOW-UP 1/27/97 1200 SPOKE TO SOMEONE AT HOSP WHO SAID TO CALL AFTER 2PM. 1/27/97 1630 MESSAGE AND 800 # LEFT FOR SURGEON TO CALL BACK. 1/27/97 1645 SURGEON RETURNED CALL AND STATED THE DEVICE CRUNCHED ONCE AND HE COULD NOT FIRE IT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA J45303

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other