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

Catalog Number SEE H.10 FOR INFORMATION

Device Problem Defective Device (2588)

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

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The impacted devices are as follows: rd10r-sp07x-000: lot 208140698 0126807.Rd10r-sp06x-000: lot 208140700 0127201.Rd10r-sp06x-000: lot 208140693 0124951.A preliminary risk assessment was conducted for this issue on august 4, 2020.According to the assessment and as documented in the event description, the surgical tech on site stated the bent electrodes did not cause a significant delay during surgery as extra electrodes were on hand.However, had the electrodes been used the possibility to damage healthy tissue remains.Therefore, the more conservative harm, mechanical energy, with the higher severity, 4, was used.Additionally, in february 2020, a medical expert was contact via email to determine the likelihood of a bent depth electrode impacting patient safety.The medical expert confirmed that a bent electrode could cause serious injury.

Event Description

On july 9, 2020 an ad-tech clinical specialist received an email from a customer stating that she had three (3) bent electrodes.She later told the clinical specialist that during a case on (b)(6) 2020, she had handed the electrode to the surgeon.Prior to placing the electrode in the cannula, he noticed that the electrode was bent.He stopped and asked for a replacement.This happened with 3 electrodes during the case.The surgical tech stated that there was no significant delay in surgery since they had extras available.The electrodes were removed from the packaging but did not come in contact with the patient.

• Brand Name: DEPTH ELECTRODE
• Type of Device: SPENCER DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer Contact: kathleen barlow ; 400 west oakview parkway; oak creek, wi ; 6341555301
• MDR Report Key: 10371467
• MDR Text Key: 238830436
• Report Number: 2183456-2020-00022
• Device Sequence Number: 1
• Product Code: GZL
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SEE H.10 FOR INFORMATION
• Device Lot Number: SEE H.10 FOR INFORMATION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1