BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4382179 · Received January 5, 2015

    Report

    Report Number
    9680837-2015-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Report Date
    December 11, 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

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT: CEV225 MONOPOLAR HOOK LOT #140701 (X2); CEV225 MONOPOLAR HOOK LOT #140703 (X3); CEV225 MONOPOLAR HOOK, LOT #140201 (X1); CEV225 MONOPOLAR HOOK LOT #140601 (X1). (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, THE INSTRUMENTS WERE RETURNED FOR EVALUATION AND REPAIR WITH REPORTED "SHEATHS ISSUES". PRODUCT ANALYSIS FOUND THE ELECTRICAL INSULATION COMPROMISED. THERE WAS NO REPORT OF PATIENT/USER IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4052 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV225 140701

    Patients

    Seq Age Sex Outcome Treatment
    1