MAUDE Adverse Event Report: DIXI MEDICAL SAS KIP-ACS-600 DURA ELECTRODE; COAGULATION ELECTRODE

Model Number	5142.6000.000A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: KIP-ACS-600 DURA ELECTRODE
• Common Device Name: COAGULATION ELECTRODE
• Manufacturer (Section D): DIXI MEDICAL SAS; 2a rte de pouligney; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• Manufacturer (Section G): DIXI MEDICAL SAS; 2a rte de pouligney; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• Manufacturer Contact: cedric boesch ; 2a rte de pouligney; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• MDR Report Key: 14727314
• Report Number: 3014527920-2022-00001
• Device Sequence Number: 17554951
• Product Code: GZL
• UDI-Device Identifier: 03664539002910
• UDI-Public: 03664539002910
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Model Number: 5142.6000.000A
• Device Catalogue Number: KIP-ACS-600
• Device Lot Number: 204244-09/21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown