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

Model Number	3334800T
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overheating found during testing of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During testing service and repair observed overheating.There was no known impact or consequence to patient.
Additional Manufacturer Narrative
The product analysis result indicates that there was no fault.Performed pre-temperature repair test and unit operated within normal parameters.Temperature were nose-87, middle-84, rear-89.However, as a precautionary measure, replaced nose bearings, nose spacer, wave washer and ceramic bearings.Unit was tested to manufacturing specifications.Fdr and fdc no longer apply.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® HANDPIECE - VISAO®
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9925936
• Report Number: 1045254-2020-00211
• Device Sequence Number: 11581182
• Product Code: ERL
• UDI-Device Identifier: 00643169360945
• UDI-Public: 00643169360945
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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 Model Number: 3334800T
• Device Catalogue Number: 3334800T
• Device Lot Number: 212180196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/04/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1