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	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Could not verify that the hand piece generated heat because the hand piece would not turn on.Disassembled housing and found the seals were worn.Bearings, motor and housing were corroded due to dried saline, which could cause that handpiece to run hot.Replaced the seal, bearings, motor and cable.After removing and cleaning the thumbwheel, the thumb wheel works fine.Item was repaired cleaned and tested and passed all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device motor is getting hot.There was no patient impact.

• 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: 7648227
• Report Number: 1045254-2018-00269
• Device Sequence Number: 16557021
• Product Code: ERL
• UDI-Device Identifier: 00613994598301
• UDI-Public: 00613994598301
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K041523
• 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): 06/28/2018

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: 1898200TRF
• Device Catalogue Number: 1898200TRF
• Device Lot Number: 71658600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1