BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS CEV134 BIPOLAR 350MM MOUIEL

    MDR report key: 9226067 · Received October 23, 2019

    Report

    Report Number
    2523190-2019-00125
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 14, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT NO. 3944213 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE EVALUATION VERIFIED THE COMPLAINT AS VALID. THE DEVICE DOESN'T PASS THE ELECTRICAL TEST. THE PLASTIC PART IS BURNT. 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 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.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ON (B)(6) 2019, DURING COAGULATION, THE CEV134 FORCEPS BIPOLAR 350MM MOUIEL HAD SPARKS AND FLAME BETWEEN THE FORCEPS AND THE CABLE CONNECTION. THE PRODUCT WAS IN CONTACT WITH THE PATIENT, HOWEVER THERE WAS NO INJURY OR DEATH ALLEGED. THE EVENT DID NOT INCREASE THE SURGICAL TIME. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018777 FORCEPS CEV134 BIPOLAR 350MM MOUIEL PFM16 GEI INTEGRA MICROFRANCE S.A.S. 3944213

    Patients

    Seq Age Sex Outcome Treatment
    1