BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 85100 · Received April 16, 1997

    Report

    Report Number
    1527736-1997-00628
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    March 15, 1997
    Report Date
    April 16, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ETS WHILE PERFORMING A LAP APPENDECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971812. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, CARTRIDGE PAN IN PLACE/CONDITION, CONDITION OF DRIVERS, LOCKOUT TABS ON PAN CONDITION, AND POSITION/CONDITION OF WEDGE SLEDS, NA. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, CONDITION OF CLAMPING MECHANISM, CONDITION OF FIRING MECHANISM, CONDITION OF KNIFE, CONDITION OF WEDGE BANDS, IS HYPER LOCKOUT CONDITION PRESENT, AND RESULT OF ATTEMPTED FIRING, GOOD. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "JAMMED" 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 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

    THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED THE INSTRUMENT WAS FIRED 4 TIMES AND JAMMED ON THE 4TH RELOAD (5TH FIRING). IT WOULD NOT RE-OPEN. THERE WAS NO CONSEQUENCE TO THE PT. 3/21/97 REP STATED THEY WERE ABLE TO LOOSEN THE JAWS ENOUGH TO REMOVE FROM THE TISSUE, BUT THE HANDLES DID NOT RETURN TO THE ORIGINAL POSITION. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K45X89

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other