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 Codes	Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
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 professional (hcp) reported that the handpiece was getting warm and the motor was making a funny noise.There was no known patient impact reported.
Additional Manufacturer Narrative
Analysis found that the customer's complaint of overheating could not be verified, pre-repair heat test was performed and unit operated within normal parameters.The temperature were nose-84, middle-81 and rear-87 which never exceeded.The seal and bearing was corroded.Replaced seal and bearing.The unit was repaired, cleaned, tested and passed 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: 9239011
• Report Number: 1045254-2019-00536
• Device Sequence Number: 10807506
• Product Code: ERL
• UDI-Device Identifier: 00613994598301
• UDI-Public: 00613994598301
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 1898200TRF
• Device Catalogue Number: 1898200TRF
• Device Lot Number: 65952700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1