MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - IPC® M5 AND M4 30K; BUR, EAR, NOSE AND THROAT

Model Number	1884070RTD
Medical Device Problem Codes	Overheating of Device (1437); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the three burs were smoking and giving off black residue in the nasal cavity during a functional endoscopic sinus surgery (fess) procedure.They switched to a second handpiece and still had the same issue.It wasn't until the fourth bur that the smoking had stopped.The devices were used for a frontal sinus drill out/ thick bone drill out.The irrigation was attached and was working at 30k rpm.The handpieces also became very warm gradually, both of the handpieces were functioning with burs at first.It was noted that the console was working properly.The hcp confirmed that the burs were not re-used or reprocessed.There was a procedure delay of less than 1 hour.It was also noted that they were successful with some burs from the different batch.There was no patient impact or injury.Upon follow-up, it was reported that there were a total of five burs that were smoking during the procedure.
Additional Manufacturer Narrative
Analysis found that there was a residue consistent with biological contaminants on the devices.Visually, there were varying degrees of biological contaminants compacted into the diamond grit of the burs.There were varying degrees of damage to the spiral wraps.The assembly of the burs includes a sleeve placed on the inside diameter of the inner assembly (next to the spiral wrap).The damage to the spiral wrap appears to have caused damage to the sleeve such as, misalignment, twisted, and blocked.Although the customer indicated the irrigation was working, the damage to the sleeves would have reduced the performance of the irrigation or blocked it completely.The reported black material was likely coagulated biologics discolored from temperature of the bur.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8339246
• Report Number: 1045254-2019-00081
• Device Sequence Number: 14024611
• Product Code: EQJ
• UDI-Device Identifier: 00643169434646
• UDI-Public: 00643169434646
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2019

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 Expiration Date: 10/23/2020
• Device Model Number: 1884070RTD
• Device Catalogue Number: 1884070RTD
• Device Lot Number: 0216476686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 02/19/2019; 02/19/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/18/2019; 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1