BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR

    MDR report key: 9199331 · Received October 16, 2019

    Report

    Report Number
    2523190-2019-00123
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 1, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT NO. 3875331 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE EVALUATION VERIFIED THE COMPLAINT AS VALID. THE DEVICE DOES NOT PASS THE ELECTRICAL TEST. THE PLASTIC PART IS BURNT BETWEEN THE CONNECTORS. 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). IT CAN COME FROM A DEFECT OF CLEANING OR OF DRYING OF THE INSTRUMENT DESPITE OF THE RECOMMENDATIONS OF INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBERS: 2523190-2019-00122 AND 2523190-2019-00124.

    Description of Event or Problem · 1

    2 OF 3 REPORTS. A CUSTOMER REPORTED THAT ON (B)(6) 2019, THERE WAS SMOKE ON THE CEV669B HANDLE DIA 5MM ANG BIPOLAR LOCATED AT THE PLUG CONNECTION. THERE WAS PATIENT CONTACT, HOWEVER NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LEAD TO AN INCREASE IN THE SURGICAL TIME. BIPOLAR FORCEPS WERE STERILIZED AND ASSEMBLED FOLLOWING THE HOSPITAL¿S PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993914 HANDLE CEV669B DIA 5MM ANG BIPOLAR PFM16 GEI INTEGRA MICROFRANCE S.A.S. 3875331

    Patients

    Seq Age Sex Outcome Treatment
    1