BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 82136 · Received February 20, 1997

    Report

    Report Number
    1527736-1997-00073
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 20, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D6; DEVICE RETURNED WITH NO LOT # IDENTIFICATION. 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 "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES 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.VISUAL INSPECTIONS AND RESULTS: LOCKOUT POSITION: ACDE FIRED BF UNFIR; CARTRIDGE CONDITION: A 1/3 FIRED BF UNFIR; CARTRIDGE RETURN BATCH NUMBER: AB EJ0033 C EJ00; INTRUMENT NUMBER: 135. FUNCTIONAL TESTS AND RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT: GOOD; CONDITION OF PINION GEAR: GOOD; CONDITION OF SHORT RACK: GOOD; CONDITION OF YOKE: GOOD; TEST CARTRIDGE BATCH # J00K0W.

    Description of Event or Problem · 1

    DURING A THORACOSCOPY. ON THIRD FIRING, THE DEVICE WOULD NOT FIRE. THE DEVICE MAY HAVE PREFIRED BEFORE BY ACCIDENT. THE STAPLES WERE MALFORMED AND THE DEVICE DID NOT CUT. ANOTHER EZ35W TO COMPLETE THE CASE. CLINICAL FOLLOW UP: 1/29/97 1356 MESSAGE AND 800# LEFT FOR MD CALL BACK. 1/29/97 1401 SURGEON CALLED BACK AND STATED HE WAS ANNOYED AT BEING CALLED -"THIS IS THE THIRD TIME I HAVE BEEN CONTACTED ABOUT THIS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other