BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH LINEAR CUTTERS

    MDR report key: 106751 · Received July 17, 1997

    Report

    Report Number
    1527736-1997-01691
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Date of Event
    June 18, 1997
    Report Date
    June 18, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH LINEAR CUTTERS ON 6/18/97 WHILE PERFORMING A THORACOSCOPY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973933. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K00V6?; CARTIDGE PAN IN PLACE/CONDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, UNFIRED AND POSITION/CONDITION OF WEDGE SLEDS, UNFIRED/GOOD. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, GOOD; CONDITION OF CLAMPING MECHANISM, GOOD; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGE BANDS, GOOD AND IS HYPER LOCKOUT CONDITION PRESENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DROPPED THE CARTRIDGE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE CARTRIDGE RENTENTION FEATURE WAS MEASURED AND WAS FOUND TO BE WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. 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 CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A THORACOSCOPY WHEN POSITIONING THE ETS ONTO LUNG TISSUE FOR THE INITIAL FIRING, THE CARTRIDGE POPPED OUT OF THE ANVIL INTO THE PT'S CHEST CAVITY. THE RELOAD WAS RETRIEVED WITH GRASPERS WITHOUT HARM TO THE PT. THE CARTRIDGE WAS DAMAGED BY THE GRASPERS. THE SURGEON USED ANOTHER ETS WITH MULTIPLE FIRINGS TO FINISH THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH LINEAR CUTTERS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K46L4K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other