BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 112216 · Received August 7, 1997

    Report

    Report Number
    1527736-1997-01932
    Event Type
    Malfunction
    Date Received
    August 7, 1997
    Report Date
    July 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: BENT LOCKOUT TAB. FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* ETS WHILE PERFORMING A UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 974389. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, J00M8H; CARTRIDGE PAN IN PLACE/CONDITION, DETACHED; CONDITION OF DRIVERS, 15 MISSING; LOCKOUT TABS ON PAN CONDITION, BENT AND POSITION/CONDITION OF WEDGE SLEDS, PARTIALLY FIRED (12. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE RETURNED CARTRIDGE HAD 15 DRIVERS MISSING, A DETACHED PAN, AND A BENT LOCKOUT TAB ON THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYLCE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, THE LOCKOUT TAB ON THE CARTRIDGE BECAME DAMAGED. IF THE INSTRUMENT'S FIRING CYLCE IS INTERUPTED, 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 OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THE RELOAD DID NOT WORK PROPERLY. THERE WAS NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other