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

Model Number	RD10R-SP07X-000
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr has been filed past the 30-day timeframe.Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur.As part of the investigation, a two year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Event or Problem Description
On (b)(6) 2018 ad-tech received a complaint of a stylet which had punctured through the bottom of an electrode prior to clinical use.There was no report of patient harm.

• Brand Name: RD DEPTH ELECTRODE
• Common Device Name: DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 9644690
• Report Number: 2183456-2020-00001
• Device Sequence Number: 2598898
• Product Code: GZL
• UDI-Device Identifier: 00841823107282
• UDI-Public: (01)00841823107282(17)190401(10)0107925208140640
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 04/01/2019
• Device Model Number: RD10R-SP07X-000
• Device Catalogue Number: RD10R-SP07X-000
• Device Lot Number: 208140640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other