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

Model Number 1884070RTD

Device Problems Overheating of Device (1437); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

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 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.

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.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 8339151
• MDR Text Key: 136308443
• Report Number: 1045254-2019-00080
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00643169434646
• UDI-Public: 00643169434646
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1