BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3920169 · Received July 8, 2014

    Report

    Report Number
    9680837-2014-00054
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 16, 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: ID# CEV134 BIPOLAR FORCEPS LOT# 090205, MFR DT: 02/2009; ID# CEV134, BIPOLAR FORCEPS, LOT# 08-06, MFR DT# 08/2006. (B)(4): THE INSTRUMENTS WERE RETURNED FOR REPAIR. SERVICE EVALUATION FOUND THE INSTRUMENTS ¿FAILED ELECTRICAL TESTING AND THE BLACK PLASTIC PARTS ARE BURNT AT THE CONNECTION. THE COATING NEXT TO THE JAWS OF THE FORCEPS WITH THE LOT 120701 IS DAMAGED, WITHOUT COMPROMISING THE INTEGRITY OF THE COATING. THE BURN OF THE PLASTIC PART IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC, PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). THE COATING DAMAGES ARE IN ALL LIKELIHOOD DUE TO A CLEANING WITH AN ABRASIVE MATERIAL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENTS WERE RETURNED FOR EVALUATION AND REPAIR. THE SERVICE EVALUATION FOUND THE INSTRUMENTS FAILED ELECTRICAL TESTING AND ¿THE BLACK PLASTIC PARTS ARE BURNT AT THE CONNECTION.¿ THERE WAS NO REPORT OF PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397473 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV134 120701

    Patients

    Seq Age Sex Outcome Treatment
    1