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

Catalog Number TBD

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

A request for additional information was sent on 01/03/2024 to the initial reporter to obtain details for the investigation.

Event Description

A medwatch report mw5149265 was received on 01/03/2024 in regards to a patient under going removal of a fractured electrode.Post-operative imaging demonstrated a retained fractured portion which required a return to the operating room for removal.

Manufacturer Narrative

A request for additional information was sent on 01/03/2024 to the initial reporter to obtain details for the investigation.Updated 03/08/2024.No batch was identified, no device history record could be conducted.As ad-tech was notified of this event by the fda, very little information was provided via report (b)(4), while we were able to contact the customer and obtain a checklist, not enough information was provided to determine a root cause.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "acceptable".No further action is needed at this time.

Event Description

A medwatch report mw5149265 was received on 01/03/2024 in regards to a patient under going removal of a fractured electrode.Post-operative imaging demonstrated a retained fractured portion which required a return to the operating room for removal.

• 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: 18487434
• MDR Text Key: 332580104
• Report Number: 2183456-2024-00002
• 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,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: TBD
• Device Lot Number: 828829830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5149265
• Patient Sequence Number: 1
• Patient Outcome(s): Other