BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16280187 · Received February 1, 2023

    Report

    Report Number
    3014527920-2023-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 1, 2023
    Manufacturer
    DIXI MEDICAL SAS
    Product Code
    GZL
    UDI-DI
    03664539002910
    PMA / PMN Number
    K170959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REFER TO THE INVESTIGATION REPORT RC-2301-009 INVESTIGATION REPORT_MAR 20, 2023 IN ATTACHMENT FOR ADDITIONAL DETAILS AND CONCLUSION ABOUT "INVESTIGATION FINDINGS" AND "014527920-2023-00001 MEDWATCH - ANSWER TO FDA QUESTIONS_V02" FOR ADDITIONAL RISK EVALUATION DATA.

    Description of Event or Problem · 0

    ON (B)(6) 2023, DIXI MEDICAL WAS INFORMED VIA THE INTERNAL CUSTOMER COMPLAINT MANAGEMENT SYSTEM OF AN INCIDENT THAT OCCURRED IN DUKE UNIVERSITY HOSPITAL WITH ONE COAGULATION ELECTRODE KIP-ACS-600. AFTER USING FOR 10-12 TRAJECTORIES, THE OPERATING ROOM STAFF AND A PERSON REPRESENTING DIXI NOTICED THAT THE FULL LENGTH OF THE DISTAL PIECE OF PLASTIC TOWARD THE POINTED AND ACTIVE END OF THE DURA COAGULATION ELECTRODE WAS NO LONGER ON THE ELECTRODE. IT WAS NOT FOUND BY THE OPERATING ROOM STAFF AFTER SCANNING THE PATIENT AND SEARCHING THE STERILE FIELD AND OPERATING ROOM. THE SURGEON DID NOT SEEM UPSET AND THEY GOT A NEW DURA COAGULATION ELECTRODE AND IT LASTED THE REMAINDER OF THE CASE, ABOUT 5-7 TRAJECTORIES. ON (B)(6) 2023, DIXI MEDICAL WAS INFORMED VIA AN ADDENDUM OF THE INITIAL CUSTOMER COMPLAINT THAT AFTER REMOVING THE DEPTH ELECTRODES FROM THE PATIENT, DUKE STAFF NOTICED THAT AN ELECTRODE LOOKED LIKE IT MAY HAVE BEEN RETAINED EVEN THOUGH THEY COUNTED ALL ELECTRODES THAT WERE IMPLANTED AND REMOVED AND THEY MATCHED. AFTER INVESTIGATION AND BRINGING THE PATIENT BACK TO SURGERY, THEY FOUND THAT THE REDUCED DIAMETER PIECE OF PLASTIC FROM THE KIP-ACS-600 IN QUESTION WAS LEFT EXTRA AND INTRACRANIAL IN THE PATIENT. PIECES OF THE REDUCED DIAMETER PORTION OF PLASTIC FROM THE KIP-ACS-600 THAT WAS LOST WERE RETRIEVED FROM THE PATIENT AND THE AMOUNT WAS CONSIDERED SUFFICIENT BY DUKE SURGEONS BASED ON THE ESTIMATED LENGTH OF PLASTIC THAT CAME OFF OF THE COAGULATION ELECTRODE. THE PIECES OF PLASTIC WERE KEPT AND SENT TO THE PATHOLOGY LAB AT DUKE AND WILL BE GIVEN BACK TO DIXI FOR INVESTIGATION.

    Description of Event or Problem · 0

    ON JANUARY 25, 2023, DIXI MEDICAL WAS INFORMED VIA THE INTERNAL CUSTOMER COMPLAINT MANAGEMENT SYSTEM OF AN INCIDENT THAT OCCURRED IN (B)(6) HOSPITAL WITH ONE COAGULATION ELECTRODE KIP-ACS-600. AFTER USING FOR 10-12 TRAJECTORIES, THE OR STAFF AND A PERSON REPRESENTING DIXI NOTICED THAT THE FULL LENGTH OF THE DISTAL PIECE OF PLASTIC TOWARD THE POINTED AND ACTIVE END OF THE DURA COAGULATION ELECTRODE WAS NO LONGER ON THE ELECTRODE. IT WAS NOT FOUND BY THE OR STAFF AFTER SCANNING THE PATIENT AND SEARCHING THE STERILE FIELD AND OPERATING ROOM. THE SURGEON DID NOT SEEM UPSET AND THEY GOT A NEW DURA COAGULATION ELECTRODE AND IT LASTED THE REMAINDER OF THE CASE, ABOUT 5-7 TRAJECTORIES. ON (B)(6), 2023, DIXI MEDICAL WAS INFORMED VIA AN ADDENDUM OF THE INITIAL CUSTOMER COMPLAINT THAT AFTER REMOVING THE DEPTH ELECTRODES FROM THE PATIENT, (B)(6) STAFF NOTICED THAT AN ELECTRODE LOOKED LIKE IT MAY HAVE BEEN RETAINED EVEN THOUGH THEY COUNTED ALL ELECTRODES THAT WERE IMPLANTED AND REMOVED AND THEY MATCHED. AFTER INVESTIGATION AND BRINGING THE PATIENT BACK TO SURGERY, THEY FOUND THAT THE REDUCED DIAMETER PIECE OF PLASTIC FROM THE KIP-ACS-600 IN QUESTION WAS LEFT EXTRA AND INTRACRANIAL IN THE PATIENT. PIECES OF THE REDUCED DIAMETER PORTION OF PLASTIC FROM THE KIP-ACS-600 THAT WAS LOST WERE RETRIEVED FROM THE PATIENT AND THE AMOUNT WAS CONSIDERED SUFFICIENT BY (B)(6)SURGEONS BASED ON THE ESTIMATED LENGTH OF PLASTIC THAT CAME OFF OF THE COAGULATION ELECTRODE. THE PIECES OF PLASTIC WERE KEPT AND SENT TO THE PATHOLOGY LAB AT (B)(6) AND WILL BE GIVEN BACK TO DIXI FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375660 NA COAGULATION ELECTRODE GZL DIXI MEDICAL SAS COAGULATION ELECTRODE AND STOP UNKOWN 03664539002910

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention| H