BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4249892 · Received November 14, 2014

    Report

    Report Number
    9680837-2014-00098
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 23, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCOMITANT DEVICES: - CEV605G: SCISSORS INSERT CEV605G 3PK 310MM, LOT 101101 MANUFACTURED NOVEMBER 2010, 510K: K993655 - CEV634-1A: BIPOLAR INSERT CEV634-1A MOUIEL, LOT 140103 MANUFACTURED JANUARY 2014, 510K: K993655 - CEV669E: HANDLE CEV669E DIA 5MM ERG BIPOLAR, LOT 140402, MANUFACTURED APRIL 2014, 510K: K993655. (B)(4): PRODUCT EVALUATION: ANALYSIS ON CEV625H, BIPOLAR INSERT, FOUND THAT ONE OF THE CERAMIC PLATES IS BROKEN. THERE IS A MISSING FRAGMENT ON THE WORKING END; BUT, IT WAS CONFIRMED THAT IT WAS NOT LEFT IN THE PATIENT. THE MOST PROBABLE CAUSE OF THIS BREAKAGE IS A SHOCK DURING THE USE OR THE REPROCESSING OF THE INSTRUMENT. ANALYSIS ON CEV605G, SCISSORS INSERT, FOUND THAT THE U-PART ON THE DISTAL END OF THE INSERT IS BROKEN. NO MATERIAL OR MANUFACTURING DEFECT WAS FOUND. THIS PART PROBABLY BROKE BECAUSE OF EXCESSIVE CONSTRAINTS DURING THE USE OR THE REPROCESSING OF THE INSERT. ANALYSIS ON CEV634-1A, BIPOLAR INSERT, FOUND THAT THE INSERT IS HARD TO ASSEMBLE ON A HANDLE. THE BIPOLAR CONNECTORS ON THE PROXIMAL END ARE DISTORTED. ONE OF THE TWO WIRES IS SLIGHTLY MORE FORWARD. NO GLUING DEFECT WAS FOUND. THE CONNECTORS PROBABLY WENT UNDER EXCESSIVE CONSTRAINTS DURING THE ASSEMBLY OF THE INSERT. ANALYSIS ON CEV669E, HANDLE, FOUND NO HIGHLIGHTED ISSUE; THE HANDLE IS COMPLIANT WITH THE MANUFACTURING SPECIFICATIONS. RESULTS: FRACTURE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH A REQUEST FOR REPAIR. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND THAT ONE OF THE CERAMIC PLATES IS BROKEN. THERE IS A MISSING FRAGMENT ON THE WORKING END; BUT, IT WAS CONFIRMED THAT IT WAS NOT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737231 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV625H 140408

    Patients

    Seq Age Sex Outcome Treatment
    1