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

Model Number SD08R-SP05X-000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Impacted device: sd08r-sp05x-000 lot#726727728 wo#135028.The preliminary risk assessment was conducted for this issue on (b)(6) 2020.According to the assessment and as documented in the event description, the customer stated they decided not to use the electrode with the bent end before the first contact as they did not want to risk the electrode deviating from the target location due to the bend.Because of the concern for a trajectory deviation through potentially healthy brain tissue if the electrode were to be used, the potential harm of damage to healthy tissue remains.Therefore, mechanical energy, with a severity of 4 was used.Additionally, in sept 2020 a medical expert was contacted via email to determine the likelihood of a bent tip impacting patient safety.The medical expert confirmed that this type of bend could cause injury.

Event Description

Customer stated upon taking the electrode out of the package the tip was found to be bent.The electrode was not used, a different electrode was used.

• Brand Name: SD 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: nicole remer ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 10554710
• MDR Text Key: 207608372
• Report Number: 2183456-2020-00024
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823107695
• UDI-Public: (01)00841823107695(17)211101(10)0135028726727728
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2020

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: 11/01/2021
• Device Model Number: SD08R-SP05X-000
• Device Catalogue Number: SD08R-SP05X-000
• Device Lot Number: 726727728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1