BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR HANDLE CEV669BG DIA 5MM ERG

    MDR report key: 18361626 · Received December 20, 2023

    Report

    Report Number
    3003249645-2023-00037
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DIA 5MM ERG BIPOLAR HANDLE (CEV669BG) WAS RETURNED FOR EVALUATION" THE DEVICE HISTORY RECORD (DHR) FOR LOT NO. 3211293 WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. FAILURE ANALYSIS: EVALUATION OF THE BIPOLAR HANDLE VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. THE HANDLE FAILED THE ELECTRICAL TEST. THE BLACK PLASTIC PART WAS BURNT AT THE CONNECTION. THERE WAS NO ELECTRICAL RISK FOR PATIENT OR USER AS THERE WAS A SHORT-CIRCUIT INSIDE THE HANDLE DURING USE. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT THE REPORTED BURNS ON THE PLASTIC PART WERE LIKELY THE CONSEQUENCE OF THE FORMATION OF A SHORT CIRCUIT WITH AN ELECTRIC ARC INSIDE THE DEVICE DUE TO THE PRESENCE OF HUMIDITY/RESIDUES IN THE CONNECTION ZONE. THESE ELECTRIC ARCS COULD ENTAIL SPARKS, SMOKE OR CRACKING. THE ORIGIN OF THE HUMIDITY RESPONSIBLE FOR THESE REPORTED COMPLAINTS COULD BE: SOME RESIDUAL HUMIDITY THAT WAS PRESENT BEFORE USE FROM A LACK OF DRYING OF THE DEVICE OR OF THE CABLE DURING REPROCESSING OR A DEFECT OF CLEANING OF THE INSTRUMENT (BLOOD OR TISSUES); SOME INFILTRATION OF BODY FLUIDS FROM THE PATIENT ALONG THE TUBE DURING SURGERY; SOME CONTAMINATION BY FLUIDS DURING SURGERY I.E. LIQUID SPILLED ON THE HANDLE DURING SURGERY , OR INSTRUMENT IN CONTACT WITH LIQUIDS WHEN NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN (B)(6) 2023, THE DIA 5MM ERG BIPOLAR HANDLE (CEV669BG) DID NOT FUNCTION. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS IN CONTACT WITH A PATIENT. THERE WAS NO PATIENT INJURY AND THE THE EVENT DID NOT LEAD TO AN INCREASE IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163460 BIPOLAR HANDLE CEV669BG DIA 5MM ERG PFM16 GEI INTEGRA MICROFRANCE S.A.S. 3211293

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown