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

Model Number	RD10R-SP06X-000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2020-00014 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 (2) 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 bent 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
• MDR Report Key: 9709152
• Report Number: 2183456-2020-00014
• Device Sequence Number: 3350978
• Product Code: GZL
• UDI-Device Identifier: 00841823107275
• UDI-Public: (01)00841823107275(17)200701(10)0121551208140681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: RD10R-SP06X-000
• Device Catalogue Number: RD10R-SP06X-000
• Device Lot Number: 208140681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 02/13/2020
• 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