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 Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The drill has been returned and the incoming inspection has been performed.The pre-repair temperatures tests confirmed reported event, the device was overheating.The following are the pre-temperature test results: 38.5 c at the rear, 29.3 c at the middle, and 59.5 c at the nose.The device is pending repair.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the device overheated after a few minutes of use during a tympanoplasty.The product analysis confirms the reported event of overheating.There was no delay to the procedure and no injuries reported as a result of this event.
Additional Manufacturer Narrative
The incoming service inspection confirmed the reported event.The analysis indicated the motor cable assembly, the collar, o-rings, and the bearing were worn.The worn components were replaced, the device tested to specifications and returned to the customer.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: 6997676
• Report Number: 1045254-2017-00391
• Device Sequence Number: 1292545
• Product Code: ERL
• UDI-Device Identifier: 00885074107349
• UDI-Public: 00885074107349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 65502100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1