BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 79103 · Received March 24, 1997

    Report

    Report Number
    1527736-1997-00318
    Event Type
    Malfunction
    Date Received
    March 24, 1997
    Date of Event
    February 3, 1997
    Report Date
    March 24, 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

    H6; CODE 400: BENT LOCKCOUT TABS ON CARTRIDGE. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ETS FLEX WHILE PERFORMING A V.A.T.S.. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO US WITH PRODUCT INQUIRY #971542. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER J00N2K, CARTRIDGE PAN IN PLACE/CONDITION YES, CONDTION OF DRIVERS GOOD, LOCKOUT TABS ON PAN CONDITION BENT, POSITION/CONDITION OF WEDGE SLEDS 1/8 FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT GOOD, CONDITION OF CLAMPING MECHANISM GOOD, CONDITION OF FIRING MECHANISM GOOD, CONDITION OF KNIFE GOOD, CONDITION OF WEDGE BANDS GOOD, IS HYPER LOCKOUT CONDITION PRESENT NO, RESULT OF ATTEMPTED FIRING GOOD. 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 "COULD NOT BE FIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE RETURNED CARTRIDGE HAD BENT LOCKOUT TABS O N THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, STOPPED, THEN RESTARTED. THE LOCKOUT TABS BECAME BENT WHEN THE FIRING CYCLE WAS RESTARTED. 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 DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE SURGEON COULD NOT FIRE THE DEVICE ON THE THIRD FIRING. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE DID NOT STAPLE THE TISSUE. A NEW DEVICE WAS INTRODUCED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA J00P2M, UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other