MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	1898200TRF
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hand-piece has been returned and the incoming inspection has been performed.The following are the findings: could not verify customer concerns regarding heat-related issues.The hp, when connected to an ipc, displays error codes 11 <(>&<)> 12 which is indicative of a seized motor.
Event or Problem Description
The customer indicated the hand-piece was overheating during use.No patient impact reported as a result of this event.
Additional Manufacturer Narrative
The servicing has been completed.The seals and bearings were found worn and the housing and motor were found corroded.The seals, bearing and the motor cable assembly were replaced.The device tested to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6998441
• Report Number: 1045254-2017-00392
• Device Sequence Number: 11058910
• Product Code: ERL
• UDI-Device Identifier: 00613994598301
• UDI-Public: 00613994598301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041413
• 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): 11/21/2017

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: 1898200TRF
• Device Catalogue Number: 1898200TRF
• Device Lot Number: 205713445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1