BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIP-ACS-600 DURA ELECTRODE

    MDR report key: 14727314 · Received June 17, 2022

    Report

    Report Number
    3014527920-2022-00001
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 16, 2022
    Manufacturer
    DIXI MEDICAL SAS
    Product Code
    GZL
    UDI-DI
    03664539002910
    PMA / PMN Number
    K170959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF EVENTS: ON (B)(6) 2022, DIXI MEDICAL USA NOTIFIED US OF A CUSTOMER COMPLAINT FROM CHARLES SHOR CENTER FOR EPILEPSY CLEVELAND CLINIC. THE COMPLAINT IS RELATED TO THE KIP-ACS-600 DURA ELECTRODE DEVICE (LOT NUMBER 204244-09/21) WITH A BREAKAGE OF ITS INSULATING PART (REFER TO PICTURE IN ATTACHMENT). ON (B)(6) 2022 CUSTOMER COMPLAINT (B)(4) WAS OPENED AT DIXI MEDICAL. ON (B)(6) 2022, REQUEST MADE FOR ADDITIONAL INFORMATION. ON (B)(6) 2022, RECEPTION OF THE DEVICE AND START OF TECHNICAL AND DOCUMENTARY INVESTIGATION. ON (B)(6) 2022, DIXI MEDICAL USA INFORMS US THAT THE INSULATING CERAMIC PART HAVING DETACHED FROM THE DEVICE ENTERED THE PATIENT'S CRANIUM REQUIRING FURTHER SURGERY. THIS NEW INFORMATION WAS TAKEN INTO ACCOUNT IN THE DECISION TO REPORT THE CASE TO THE FDA. AT THIS STAGE DOCUMENTATION AND TECHNICAL INVESTIGATION HAVE BEEN DONE WITHOUT DETECTING ISSUES ON THE DEVICE. FURTHER INVESTIGATION ARE ON-GOING RELATED TO THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF EVENTS: ON MARCH 18, 2022, DIXI MEDICAL USA NOTIFIED US OF A CUSTOMER COMPLAINT FROM (B)(6) CLINIC. THE COMPLAINT IS RELATED TO THE KIP-ACS-600 DURA ELECTRODE DEVICE (LOT NUMBER 204244-09/21) WITH A BREAKAGE OF ITS INSULATING PART. ON (B)(6) 2022, CUSTOMER COMPLAINT (B)(4) WAS OPENED AT DIXI MEDICAL. ON APRIL 6 & 20, 2022, REQUEST MADE FOR ADDITIONAL INFORMATION ON MAY 5, 2022, RECEPTION OF THE DEVICE AND START OF TECHNICAL AND DOCUMENTARY INVESTIGATION. ON MAY 17, 2022, DIXI MEDICAL USA INFORMS US THAT THE INSULATING CERAMIC PART HAVING DETACHED FROM THE DEVICE ENTERED THE PATIENT'S CRANIUM REQUIRING FURTHER SURGERY. THIS NEW INFORMATION WAS TAKEN INTO ACCOUNT IN THE DECISION TO REPORT THE CASE TO THE FDA. AT THIS STAGE DOCUMENTATION AND TECHNICAL INVESTIGATION HAVE BEEN DONE WITHOUT DETECTING ISSUES ON THE DEVICE. FURTHER INVESTIGATION ARE ON-GOING RELATED TO THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, DIXI MEDICAL USA NOTIFIED DIXI MEDICAL OF A CUSTOMER COMPLAINT FROM CLEVELAND CLINIC (COMPLAINT (B)(4)). THE COMPLAINT IS RELATED TO THE KIP-ACS-600 DURA ELECTRODE DEVICE (LOT NUMBER 204244-09/21) WITH A BREAKAGE OF ITS INSULATING PART AT THE DISTAL END OF THE PRODUCT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS SENT TO US CONCERNING THE FACT THAT THE CERAMIC PIECE HAS PENETRATED INSIDE THE CRANIAL BOX AND A NEW SURGERY IS REQUIRED TO REMOVE IT. THIS NEW INFORMATION LED TO THE DECISION TO REPORT THE CASE.

    Description of Event or Problem · 0

    ON MARCH 18, 2022, DIXI MEDICAL USA NOTIFIED DIXI MEDICAL OF A CUSTOMER COMPLAINT FROM (B)(6) CLINIC COMPLAINT (B)(4). THE COMPLAINT IS RELATED TO THE KIP-ACS-600 DURA ELECTRODE DEVICE (LOT NUMBER 204244-09/21) WITH A BREAKAGE OF ITS INSULATING PART AT THE DISTAL END OF THE PRODUCT. ON MAY 17, 2022, ADDITIONAL INFORMATION WAS SENT TO US CONCERNING THE FACT THAT THE CERAMIC PIECE HAS PENETRATED INSIDE THE CRANIAL BOX AND A NEW SURGERY IS REQUIRED TO REMOVE IT. THIS NEW INFORMATION LED TO THE DECISION TO REPORT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202888 KIP-ACS-600 DURA ELECTRODE COAGULATION ELECTRODE GZL DIXI MEDICAL SAS 5142.6000.000A 204244-09/21 03664539002910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown