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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation and repair.The cable was found cut.The device was not tested for heating, the device was repaired prior to receiving additional information from the customer.The cable assembly was replaced and the device was repaired to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The initial report from the customer on (b)(6) 2018 indicated the device was not working.No patient impact reported additional information was received from a healthcare professional (hcp) regarding a hand-piece.It was reported that the device was not working and heated up instantaneously when used for testing purposes prior to decontamination.The hcp noted that they had tested the device prior to putting it in service and that it was never used in the operating room (or).There was no patient or staff impact.

• 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: 7401589
• Report Number: 1045254-2018-00154
• Device Sequence Number: 993402
• Product Code: HBE
• UDI-Device Identifier: 00613994790217
• UDI-Public: 00613994790217
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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: 209928990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1