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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that the handpiece was overheating during operation.There was no patient or staff impact.
Additional Manufacturer Narrative
Product analysis: could not verify excessive heat.Performed pre-temperature test.Ambient temperature was 73.7 and in 1 minute of testing handpiece temperature were t1 - 75.8 and t2 - 76.9 unit operated within normal parameters.Examined item, no fault found.Handpiece was cleaned, tested and passed to 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: 8939025
• Report Number: 1045254-2019-00416
• Device Sequence Number: 14105733
• Product Code: HBE
• UDI-Device Identifier: 00613994633897
• UDI-Public: 00613994633897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 205913810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1