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

Model Number	TS08R-SP10X-000
Medical Device Problem Codes	Material Separation (1562); Material Twisted/Bent (2981); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that electrode strip was bent and 2 contacts separated from the strip and had to be retrieved from the patient.
Additional Manufacturer Narrative
The customer has not reported information on patient impact.We are currently seeking more information to conduct a thorough investigation.The customer has been emailed several times to gather follow-up information.At this time we have insufficient information.
Event or Problem Description
A customer reported that electrode strip was bent and 2 contacts separated from the strip and had to be retrieved from the patient.
Additional Manufacturer Narrative
The customer has not reported information on patient impact.We are currently seeking more information to conduct a thorough investigation.The customer has been emailed several times to gather follow-up information.At this time we have insufficient information.Updated (b)(6)2024 no product was returned or checklist with additional information was supplied by the customer.Several attempts were made to obtain but were unsuccessful.With the limited information supplied by the customer no root cause could be identified.There are no corrective actions.
Event or Problem Description
A customer reported that electrode strip was bent and 2 contacts separated from the strip and had to be retrieved from the patient.
Additional Manufacturer Narrative
The customer has not reported information on patient impact.We are currently seeking more information to conduct a thorough investigation.The customer has been emailed several times to gather follow-up information.At this time, we have insufficient information.Updated 06/28/24.No product was returned or checklist with additional information was supplied by the customer.Several attempts were made to obtain but were unsuccessful.With the limited information supplied by the customer no root cause could be identified.There are no corrective actions.Updated 09/27/2024.Udi related data quality updates only.Clarification and correction of the following missing items from previous supplemental report: combination product- no.Brand name- subdural electrode.Model and catalog number ts08r-sp10x-000.Primary di number- (b)(4).

• Brand Name: SUBDURAL ELECTRODE
• Common Device Name: SUBDURAL 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: 19434718
• Report Number: 2183456-2024-00008
• Device Sequence Number: 8456812
• Product Code: GYC
• UDI-Device Identifier: 00841823108197
• UDI-Public: 00841823108197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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?: Yes
• Device Expiration Date: 03/01/2025
• Device Model Number: TS08R-SP10X-000
• Device Catalogue Number: TS08R-SP10X-000
• Device Lot Number: 834835836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 05/07/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/28/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown