MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SUBDURAL STRIP ELECTRODE; SUBDURAL ELECTRODE, PRODUCT CODE: GYC

Model Number	TS04R-SP10X-000
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 8/3/2022 ad-tech received a complaint from nihon kohden stating that during their incoming inspection process they found foreign material on a ts04r-sp10x-000 electrode pouch.During review of the complaint information it was determined on 9/1/2022 that an mdr was not needed, as the product had not been returned as of yet and the picture provided by the customer appeared to show foreign material on the pouch rather than inside of the pouch.The product return was received on 9/14/2022, and on 9/21/2022 it was determined an mdr was needed since adhesive was found inside the inner pouch with the subdural electrode.
Event or Problem Description
During routine incoming inspection the distributor noted a foreign material in the sterile product pouch.There was no impact to patient safety as this was identified during incoming inspection.
Event or Problem Description
During routine incoming inspection the distributor noted a foreign material in the sterile product pouch.There was no impact to patient safety as this was identified during incoming inspection.
Additional Manufacturer Narrative
On 8/3/2022 ad-tech received a complaint from nihon kohden stating that during their incoming inspection process they found foreign material on a ts04r-sp10x-000 electrode pouch.During review of the complaint information it was determined on 9/1/2022 that an mdr was not needed, as the product had not been returned as of yet and the picture provided by the customer appeared to show foreign material on the pouch rather than inside of the pouch.The product return was received on 9/14/2022, and on 9/21/2022 it was determined an mdr was needed since adhesive was found inside the inner pouch with the subdural electrode.--updated: 11/18/2022--- the foreign material was found to be located in the inner pouch with the product.Based on the texture and appearance, the foreign material is most likely a piece of adhesive used in the production of this product.The root cause was determined to be that the adhesive was most likely stuck to the product during final qc cleaning and packaging, and was not seen during the lint check conducted prior to sterilization and was not seen during final packaging in finished goods prior to shipment.All employees involved with these steps were notified and acknowledged the error.The risk assessment concluded that the calculated occurence remains "alap" (as low as possible) and no further action is needed at this time.

• Brand Name: SUBDURAL STRIP ELECTRODE
• Common Device Name: SUBDURAL ELECTRODE, PRODUCT CODE: GYC
• 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: nicole remer ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 15579728
• Report Number: 2183456-2022-00019
• Device Sequence Number: 17759952
• Product Code: GYC
• UDI-Device Identifier: 00841823108012
• UDI-Public: (01)00841823108012(17)240301(10)0154348798799800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 03/01/2024
• Device Model Number: TS04R-SP10X-000
• Device Catalogue Number: TS04R-SP10X-000
• Device Lot Number: 798799800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown