MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SPENCER PROBE ELECTRODES

Model Number	SD06R-SP10X-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the event description, this issue was identified at the distributor's site during the incoming inspection of the product.A foreign substance (black ink) had been identified in the product pouch (see attached picture).There was no impact to patient safety as the issue was identified during inspection at the distributor's site and was not delivered to a customer yet.A medical expert was contacted via email to determine if the foreign substance could impact patient safety, should the ink make contact with the brain.Ad-tech's complaint team is currently waiting for a response.As a conservative measure, an mdr was filed.
Event or Problem Description
On november 12, 2019, ad-tech received an email from one of their distributors stating that during their incoming inspection of the product, they identified a foreign substance (black ink) in the product pouch.There was no impact to patient safety as the issue was identified during inspection at the distributor's site and was not delivered to a customer yet.

• Brand Name: SPENCER PROBE ELECTRODES
• Common Device Name: SPENCER PROBE ELECTRODES
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek 53154
• MDR Report Key: 9461653
• Report Number: 2183456-2019-00045
• Device Sequence Number: 502194
• Product Code: GZL
• UDI-Device Identifier: 00841823107633
• UDI-Public: (01)00841823107633(17)210501(10)0130753208140711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: SD06R-SP10X-000
• Device Catalogue Number: SD06R-SP10X-000
• Device Lot Number: 208140711 130753
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1