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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: unknown xps console, xps3000.Product evaluation: analysis results not available; the device was not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ¿patient was set for surgery to remove large sinus polyp.Ent surgeon began to use microdebrider shaver handpiece and there was no indication the handpiece was working (no sound).Register nurse turned on/off the integrated power control panel (ipc) and unplugged/plugged in the handpiece without success.A second handpiece was retrieved and the ipc was restarted, still without success (no sound).A third handpiece was retrieved.There was minimum sound from the device, but no movement.Third handpiece did warm to touch.Ent surgeon opted to abort and reschedule procedure due to delay and length of time patient was under anesthesia.¿ there was no reported patient impact.
Additional Manufacturer Narrative
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 north; jacksonville FL 32216
• MDR Report Key: 6199833
• Report Number: 1045254-2016-00433
• Device Sequence Number: 18976519
• Product Code: ERL
• UDI-Device Identifier: 00613994598301
• UDI-Public: 00613994598301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K041413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1898200TRF
• Device Catalogue Number: 1898200TRF
• Device Lot Number: 61524800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other