BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3925354 · Received July 10, 2014

    Report

    Report Number
    9680837-2014-00055
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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

    CONCOMITANT: CEV134 - FORCEPS BIPOLAR 360MM MOUIEL, LOT: 09-03, MANUFACTURE DATE: SEPTEMBER 2003. CEV134 - FORCEPS BIPOLAR 360MM MOUIEL, LOT: 121101, MANUFACTURE DATE: NOVEMBER 2012. (B)(4): THE ANALYSIS INDICATES THAT THE BLACK PLASTIC PART IS BURNT BETWEEN THE BIPOLAR CONNECTORS. A LARGE AMOUNT OF SURGERY RESIDUE HAS BEEN FOUND IN THE FORCEPS. 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 CLEANING OF THE FORCEPS IS IN ALL LIKELIHOOD INSUFFICIENT. CEV134 (LOTS: 09-03 AND 121101): THE BLACK PLASTIC PARTS ARE BURNT AT THE CONNECTION. THE INSTRUMENTS HAVE BEEN REPAIRED BY AN EXTERNAL CONTRACTOR (WITH AN UNKNOWN ETCHING). 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). MOREOVER, THE REPAIR REALIZED BY AN EXTERNAL CONTRACTOR MAY HAVE WEAKENED THE INSTRUMENT AND LED TO THE REPORTED INCIDENT. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    THREE BIPOLAR FORCEPS (CEV133 ¿ QTY 1; CEV134 ¿ QTY 2) WERE RETURNED FOR REPAIR. THE AVAILABLE INFORMATION INDICATES THAT THE INSTRUMENTS PRESENTED WITH EVIDENCE OF HEAT DAMAGE. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403667 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV133 120401

    Patients

    Seq Age Sex Outcome Treatment
    1