MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. IPC® HANDPIECE - STYLUS TOUCH®; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	EM210
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; product was not returned for analysis.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The facility reported that the device got hot during a demo.There was no patient impact.
Additional Manufacturer Narrative
The device was returned for analysis.Analysis could not confirm the reported event of the device getting hot.Pre-repair temperature testing was performed.The following are the pre-repair temperatures of the device after 1 minute: t1 ¿ 78.2 degrees f and t2 ¿ 77.4 degrees f.The ambient temperature was 76.6 degrees f.Evaluation found no fault with the device.The device was tested to all manufacturing product specifications and returned to the customer.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received indicating that it took less than one minute for the device to get hot.

• Brand Name: IPC® HANDPIECE - STYLUS TOUCH®
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6853201
• Report Number: 1045254-2017-00316
• Device Sequence Number: 19190007
• Product Code: HBE
• UDI-Device Identifier: 00613994633897
• UDI-Public: 00613994633897
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2017

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: EM210
• Device Catalogue Number: EM210
• Device Lot Number: 205681103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 09/25/2017; 10/20/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 10/20/2017; 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1