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	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; the device was not returned for analysis.
Event or Problem Description
The physician reported that during a tympanoplasty, "when the foot switch was stepped on, the drill abnormally oscillated.The high-speed drill did not overheat but heated [got warm].The drill was not too hot to be held by hand." the procedure was completed with the reported product.There was no patient impact or injury.
Additional Manufacturer Narrative
Unique identifier (udi)#: (b)(4).Additional information from the sales rep also indicates the device was lost in the site and it is not possible to be returned.Therefore a product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from the sales rep indicates it took the handpiece approximately one minute for the device to heat up.

• 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 north; jacksonville FL 32216
• MDR Report Key: 7167413
• Report Number: 1045254-2018-00008
• Device Sequence Number: 13796031
• 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): 02/01/2018

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: 208146067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1