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

Model Number	SD08R-SP05X-000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 10554710
• Report Number: 2183456-2020-00024
• Device Sequence Number: 3538864
• Product Code: GZL
• UDI-Device Identifier: 00841823107695
• UDI-Public: (01)00841823107695(17)211101(10)0135028726727728
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1