BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCPIC VASCULAR LINEAR CUTTER

    MDR report key: 81661 · Received February 10, 1997

    Report

    Report Number
    1527736-1997-00112
    Event Type
    Malfunction
    Date Received
    February 10, 1997
    Date of Event
    January 7, 1997
    Report Date
    February 7, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    GAG
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER WHILE PERFORMING A MISC; LAP OVARIAN CYSTECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #970764. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION; A MISSING B UNFIRE. CARTRIDGE CONDITION; AB 1/4 FIRED. CARTRIDGE RETURN BATCH #; A J00E3Y B EM01. INSTRUMENT #; 152. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, AND CONDITION OF YOKE; GOOD. CONDITION OF SHORT RACK; BROKEN. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY DAMAGE TO THE INTERNAL COMPONENTS. THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE THE ANVIL ROTATED OUT OF POSITION IN THE CHANNEL, BROKEN FIRING TRIGGER TEETH, AND A BROKEN SHORT RACK. CARTRIDGE A WAS RETURNED MISSING THE LOCKOUT TAB. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. 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

    DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, IT WAS REPORTED BY THE AFFILIATE THAT THE SURGEON MANAGED TO GET THE JAWS CLOSED, THE DEVICE WOULD NOT FIRE. THIS SAME EVENT HAPPENED AFTER THE SURGEON CHANGED THE CARTRIDGE. THERE WAS NO CONSEQUENCE TO THE PT. THE RELOAD NOTED WAS A EVU35 CARTRIDGE (LOT NUMBER J41N7P: BATCH NUMBER EMD 138).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG EES-CINCINNATI NA J43L86

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other