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

Model Number	EM210RF
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; the device was not returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer reported the handpiece was getting warm.There was no patient impact.
Additional Manufacturer Narrative
Summary of analysis: the reported malfunction could not be replicated.The evaluation confirmed there was no fault found with the device.The ambient temperature was 74.9f and the rise or max temperature was 89.7f.The max temperature - the ambient temperature = 14.8f, which was passing.The max rise temperature was 27f for the drill.The item was repaired cleaned, tested and passed all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• 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: 7334676
• Report Number: 1045254-2018-00107
• Device Sequence Number: 41042
• Product Code: HBE
• UDI-Device Identifier: 00613994790217
• UDI-Public: 00613994790217
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: EM210RF
• Device Catalogue Number: EM210RF
• Device Lot Number: 214053382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1