MAUDE Adverse Event Report: DIXI MEDICAL DIXI MEDICAL COAGULATION ELECTRODE; ELECTRODE, DEPTH

Model Number KIP-ACS_600

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2023

Event Type  Injury  

Event Description

On (b)(6)2023, the patient underwent stereotactic implantation of depth electrodes into the brain for seizure monitoring.The electrodes ere placed with the (b)(6) medical dural coagulator electrode.During the placement of the electrode, it was noted cylindrical plastic sheath of the dural coagulator had shifted.The surgeon spoke with the vendor representative, who indicated that it was okay to continue using the coagulation electrode.However, a few minutes later, it was noted that the dural coagulator's 2 cm x 4 mm cylindrical plastic sheath had come entirely off the dural coagulation electrode.An extensive search occurred, but the plastic sheath could not be found.Given the large size of the sheath, it was deemed impossible that it could have been pushed inside the skull.The surgery was completed, and a ct-scan at the end of the case did not indicate a retained foreign object.(b)(6) 2023, the patient returned to the operating room to remove the intracranial electrodes placed on (b)(6)2023.A ct scan was obtained on (b)(6) 2023 after removing the stereotactic electrodes, which then identified a retained object near the tip of the right infratemporal fossa of the brain.It appears that the stereotactic electrode was preventing the sheath from being seen on the initial ct-scan that was completed on (b)(6) 2023.The pt was taken to the operating room on (b)(6) 2023 to undergo a right craniotomy to remove the retained object.During the surgical procedure it was noted the plastic sheath was imbedded into the bone and had passed through the dura touching the brain.The retained sheath was removed and a ct-scan was completed at the end of the procedure, which confirmed the retained object had been removed.In assessing the retained object it was determined to be the plastic sheath from the (b)(6) medical coagulation electrode.The pt did well and was discharged home on (b)(6) 2023.

• Brand Name: DIXI MEDICAL COAGULATION ELECTRODE
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): DIXI MEDICAL; 2a route de pouligney; marchaux-chaudefontaine 25640 ; FR 25640
• MDR Report Key: 16334440
• MDR Text Key: 309203915
• Report Number: MW5114789
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KIP-ACS_600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White