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

Model Number 1883040BLD

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

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 during an endoscopic sinusitis surgery, the bur was used at 30000 rpm with the use of the handpiece.The bur which was used overheated and the patient was burned.The hcp confirmed that the event was not attributed to overheating of handpiece.Although it was unknown how long it was continuously used, the burn mark was confirmed under the patient's nose after the procedure.It was noted that a burning scar of about 2 centimeter on the entrance of the nasal cavity.The degree was confirmed but it was known and application of ointment was performed and the patient started to recover.It was also noted that there is no possibility of causing sequela.This was the initial use of the device.The procedure was completed with the reported device and there was no procedure delay as a result of this event.

Manufacturer Narrative

Analysis for the blade.Visually, there was no damage or anomalies in the construction of the device.The inner cutter spun freely by hand.The suction port at the tip was compacted with biological material which may indicate insufficient irrigation.A syringe confirmed the irrigation path was not blocked.The bur run at 12,000 rpm in handpiece (limited to 12k), with no irrigation, and was 82 degrees f near the tip after 1 minute.Analysis for the handpiece.Couldn¿t verify the overheating.The device was working well.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: 8336991
• MDR Text Key: 136155328
• Report Number: 1045254-2019-00078
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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
• Device Operator: Health Professional
• Device Model Number: 1883040BLD
• Device Catalogue Number: 1883040BLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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