MAUDE Adverse Event Report: DIXI MEDICAL SAS; COAGULATION ELECTRODE

Model Number COAGULATION ELECTRODE AND STOP

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: NA
• Type of Device: 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: 16280187
• MDR Text Key: 308588354
• Report Number: 3014527920-2023-00001
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 03664539002910
• UDI-Public: 03664539002910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: COAGULATION ELECTRODE AND STOP
• Device Catalogue Number: KIP-ACS-600
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 18 YR
• Patient Sex: Male