BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS-KIP-600 COAGULATION ELECTRODE

    MDR report key: 17226040 · Received June 29, 2023

    Report

    Report Number
    3014527-2023-00002
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    March 27, 2023
    Report Date
    June 29, 2023
    Manufacturer
    DIXI MEDICAL SAS
    Product Code
    GZL
    PMA / PMN Number
    K170959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBMISSION OF THIS MEDWATCH RELATING TO AN INCIDENT IN FRANCE WAS SUBMITTED AFTER THE 30 DAYS REQUIRED BY US LAW. A CAPA HAS BEEN INITIATED BY DIXI MEDICAL TO REMEDY THIS DEVIATION, INCLUDING TRAINING OF INTERNAL TEAMS AND REVIEW OF PROCEDURES TO PREVENT THIS TYPE OF SITUATION IN THE FUTURE.

    Description of Event or Problem · 0

    THIS EVENT HAPPEND IN FRANCE, ACCORDING TO FDA REQUIREMENTS A MEDWATCH IS OPENED TO INFORM THE US AUTHORITIES. THIS CASE HAS BEEN REFERENCED IN A COMMUNICATION WITH (B)(6), PHD ON (B)(6) 2023 AS PER MDR 3014527920-2023-00001. SUMMARY OF THE EVENT: ON THE POST-ELECTRODE REMOVAL SCAN, THE SURGEONS NOTICED THAT THERE WAS STILL A RADIO-OPAQUE ELEMENT IN THE CRANIAL CAVITY IN THE PATH OF ONE OF THE ELECTRODES. THE PATIENT HAD TO BE RE-OPERATED AND A FOREIGN BODY WAS REMOVED. AFTER ANALYSIS, IT TURNED OUT TO BE THE SHEATH OF THE COAGULATION PROBE USED TO COAGULATE THE DURA MATER, WHICH HAD BECOME DETACHED DURING THE IMPLANTATION PROCEDURE. A MATERIOVIGILANCE DECLARATION WAS MADE TO ANSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245965 ACS-KIP-600 COAGULATION ELECTRODE COAGULATION ELECTRODE GZL DIXI MEDICAL SAS COAGULATION ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R