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

Model Number RD10R-SP07X-000

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2018

Event Type  malfunction  

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 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
• Type of Device: DEPTH 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: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 9644690
• MDR Text Key: 185089978
• Report Number: 2183456-2020-00001
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823107282
• UDI-Public: (01)00841823107282(17)190401(10)0107925208140640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other