BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4422394 · Received January 15, 2015

    Report

    Report Number
    9680837-2015-00012
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 24, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DATE RECEIVED BY MANUFACTURER: JANUARY 15, 2015.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. - CEV225: HOOK CEV225 DIA 5MM 450MM MONOPOLAR, LOT 141002 MANUFACTURED: OCTOBER 2014 - CEV225 (X3): HOOK CEV225 DIA 5MM 450MM MONOPOLAR, LOT 140701 MANUFACTURED JULY 2014 - CEV225: HOOK CEV225 DIA 5MM 450MM MONOPOLAR, LOT 140703 MANUFACTURED JULY 2014. PATIENT CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4). PRODUCT EVALUATION: ANALYSIS FOUND THAT THE BLUE COATING ON ALL OF THE HOOKS (LOTS 131201, 141002, 140701 (X 3), 140703) IS VERY DAMAGED. THE ELECTRICAL INSULATION OF THIS PART OF THE INSTRUMENT IS COMPROMISED. THE BLACK SHEATHS ARE ALSO DAMAGED ON THEIR DISTAL PARTS AND IMPACTED ON THEIR TUBES. THE INSTRUMENTS ALL PASSED ELECTRICAL TESTS. THESE INSTRUMENTS PROBABLY WENT UNDER NUMEROUS SHOCKS DURING THEIR USES AND REPROCESSING. THE BLUE COATING HAS PROBABLY BEEN DAMAGED BY THE USE OF AN ABRASIVE.

    Description of Event or Problem · 1

    THE DEVICES WERE RETURNED WITH A REPAIR REQUEST STATING THAT THERE ARE ¿6 DEFECTIVE HOOKS¿. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND THAT THE INSULATION ON THE INSTRUMENTS IS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35720 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV225 131201

    Patients

    Seq Age Sex Outcome Treatment
    1