MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR GUARD - VISAO®; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	3334635
Medical Device Problem Codes	Difficult to Insert (1316); Overheating of Device (1437); Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use, the visao drill handpiece was overheating after a few minutes of use, shaking during operation, and the visao bur guard was difficult to insert the drill into.The issue was not with the drill but with the attachment, and the drill worked well.There was no reported patient involvement.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: XPS® BUR GUARD - VISAO®
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 21331222
• Report Number: 1045254-2025-00331
• Device Sequence Number: 15608508
• Product Code: ERL
• UDI-Device Identifier: 00643169955646
• UDI-Public: 00643169955646
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K983224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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 Model Number: 3334635
• Device Catalogue Number: 3334635
• Device Lot Number: 224474218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/07/2025
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown