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

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Based on our preliminary risk assessment, it was determined that the severity of this issue calls for an mdr.This form was completed on (b)(6) 2023.While the customer reported no harm to the patient, there is the possibility of damage to healthy tissue.Out of an abundance of caution an mdr will be filed.

Event Description

On (b)(6) 2023, an ad-tech clinical specialist received an email from the independent representative stating that during removal of the depth electrode at one of their sites, the electrode became stuck and could not be removed/pulled out with the anchor bolt in tact.This forced the surgeon to unscrew the bolt while simultaneously removing the electrode.There was no reported impact to the patient.

Manufacturer Narrative

Based on our preliminary risk assessment, it was determined that the severity of this issue calls for an mdr.This form was completed on 03/20/2023.While the customer reported no harm to the patient, there is the possibility of damage to healthy tissue.Out of an abundance of caution an mdr will be filed.Updated 5-24-2023.The patient needed an additional scan to check for remnant but no patient harm was reported.The product was returned for evaluation in which the alleged complaint was confirmed that the electrode was not removed from the anchor bolt.The visual inspection found no damage to the brain end of the electrode.The electrode was severed in the main body and the rest of the electrode was not returned.An attempt to remove the bolt was made and it required excessive force.Once removed, an unidentified substance was found under the location where the bolt was stuck.The substance under the bolt potentially could have been a contributing factor but no root cause could be identified.The risk assessment concluded that the calculated occurence remains "acceptable" and no futher action is nedeed at this time.

Event Description

On february 20, 2023, an ad-tech clinical specialist received an email from the independent representative stating that during removal of the depth electrode at one of their sites, the electrode became stuck and could not be removed/pulled out with the anchor bolt in tact.This forced the surgeon to unscrew the bolt while simultaneously removing the electrode.There was no reported impact to the patient.

• 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: 16576764
• MDR Text Key: 311681373
• Report Number: 2183456-2023-00004
• 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: 05/24/2023

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 05/25/2023
• 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