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

Model Number	3334800
Medical Device Problem Codes	Overheating of Device (1437); Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: pre-check analysis confirmed that the drill body is free from mechanical damage.The color is unchanged.The cord is free from significant kinks and deformations.The plug is slightly deformed.It fits fully into the socket.The chuck tip is deformed.There are signs of contact with the drill bit.The front chuck bearing is missing.The drill bit locking mechanism is functional.The drill bit is inserted into the chuck and locks into place.The drill operates when turned on.There are no extraneous noises in the chuck.There are no coolant leaks from the motor housing.- the indicator labels are present on the plug.The drill is recognized correctly when connected to the console.The front and middle chuck bearings heat up to over 130°f for 1 minute! this is caused by worn bearings.When turned on at 80,000 rpm, the drill bit vibrates.There is excessive vibration.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.
Event or Problem Description
It was reported that during set up, handpiece had vibration issue.There was no patient impact.During analysis handpiece found to be overheating.

• Brand Name: XPS® HANDPIECE - 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: 23642349
• Report Number: 1045254-2025-02632
• Device Sequence Number: 15985752
• Product Code: ERL
• UDI-Device Identifier: 00885074107332
• UDI-Public: (01)00885074107332(11)110726
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K011321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 3334800
• Device Catalogue Number: 3334800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2011
• 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