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

Model Number RD10R-SP06X-000

Device Problem Defective Device (2588)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

A preliminary risk assessment was completed on 12-19-2022 resulting in the determination that the severity of this issue would call for a mdr.While the customer reported no harm to the patient or significant delay in procedure there is the possibility of damage to healthy tissue.Out of abundance of caution an mdr will be filed.

Event Description

On december 7th, 2022 a clinical specialist received an email from a customer.The email stated that a depth electrode was not used during surgery due to a bent tip.According to the customer, there was no impact to the patient and there was no signigicant delay in surgery as a result of this issue.

Event Description

On december 7th, 2022 a clinical specialist received an email from a customer.The email stated that a depth electrode was not used during surgery due to a bent tip.According to the customer, there was no impact to the patient and there was no signigicant delay in surgery as a result of this issue.

Manufacturer Narrative

A preliminary risk assessment was completed on (b)(6) 2022 resulting in the determination that the severity of this issue would call for a mdr.While the customer reported no harm to the patient or significant delay in procedure there is the possibility of damage to healthy tissue.Out of abundance of caution an mdr will be filed.Updated 1-12-2023.The product was returned for evaluation.The alleged complaint was confrimed and found that the elecctrode tip was bent.As part of the product evalutaion, the stylet was removed from the electrode and examined.The stylet pulled easily from the electrode tubing and showed no signs of bending or any other damamge.When fully inserted back into the electrode the stylet lessened the bend.However when the stylet was removed the bend was present at a lesser degree.The cause and time of the damage to the electrode could not be confirmed and no root cause could be identified.The risk assessment concluded that the caluclated occurrence remains "alap" (as low as possible) and no futher 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: 16106761
• MDR Text Key: 308485473
• Report Number: 2183456-2023-00002
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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 Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: RD10R-SP06X-000
• Device Catalogue Number: RD10R-SP06X-000
• Device Lot Number: 765766767R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1