MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. DEPTH ELECTRODE

Catalog Number RD10R-SP05X-000

Device Problem Separation Failure (2547)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, an in person complaint was documented for a damaged electrode during the removal process.This incident caused a 30 minute delay in procedure with no injury or patient death occurence.Once the electrode and anchor bolt were removed from the patient's skull, it was discovered that the distal tip of the electrode had broken off inside the patient.There were 4- contacts and some of the electrode body missing from the removed electrode and presumed to be remaining inside the patient's skull.An additional surgery was performed on (b)(6) 2023 to remove the remaining electrode in the patient.There was no injury or patient death.

Event Description

On february 15, 2023, an in person complaint was documented for a damaged electrode during the removal process.This incident caused a 30 minute delay in procedure with no injury or pateint death occurence.Once the electrode and anchor bolt were removed from the patient's skull, it was discovered that the distal tip of the electrode had broken off inside the patient.There were (b)(4) contacts and some of the electrode body missing from the removed electrode and presumed to be remaining inside the patient's skull.An additional surgery was performed on (b)(6) 2023 to remove the remaining electrode in the patient.There was no injury or patient death.

Manufacturer Narrative

Updated 05/25/2023.The additional surgery was successful in removing the remnant electrode parts.There was no harm to the patient.The product was returned for evaluation in which the alleged complaint was confirmed that (b)(4) contacts were missing from the brain end of the electrode.The evaluation findings do not lead to a clear root cause for the electrode damage.The risk assessment concluded that the calculated occurrence remains "alap" (as low as possible) and no further action is needed at this time.

• Brand Name: DEPTH ELECTRODE
• Type of Device: DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 16491437
• MDR Text Key: 310956133
• Report Number: 2183456-2023-00003
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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
• Device Catalogue Number: RD10R-SP05X-000
• Device Lot Number: 816817818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1