BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 81385 · Received April 2, 1997

    Report

    Report Number
    1527736-1997-00446
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ETS WHILE PERFORMING A LAP GASTRECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971684. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER; K00R58. CARTRIDGE PAN IN PLACE/CONDITION, CONDITION OF DRIVERS, AND LOCKOUT TABS ON PAN CONDITION; GOOD. POSITION/CONDITION OF WEDGE SLEDS; FULLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, CONDITION OF CLAMPING MECHANISM, CONDITION OF FIRING MECHANISM, CONDITION OF KNIFE, CONDITION OF WEDGE BANDS, AND RESULT OF ATTEMPTING FIRING; GOOD. IS HYPER LOCKOUT CONDITION PRESENT; NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "MALFORMED STAPLES" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSMEBLY 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

    DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT ON THE SECOND FIRING, SOME OF THE STAPLES MALFORMED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. 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 J45K76

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other