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	05/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed, could not perform the temperature test as the motor in the returned drill would not run.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Cusrtomer reported the em210 heated up.No patient impact.
Additional Manufacturer Narrative
Corrected information.The actual/suspect hand piece has tested for heat.The ambient starting temperature was 82.4 degrees f and rose to 88.7 degrees f after running for one minute.The maximum allowable temperature after running for one minute is 118 degrees f.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer reported the drill heated up.There was no patient injury.Analysis did not confirm a heating issue.

• 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: 7575216
• Report Number: 1045254-2018-00234
• Device Sequence Number: 11187129
• Product Code: HBE
• UDI-Device Identifier: 00613994790217
• UDI-Public: 00613994790217
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 208257716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1