MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number 1883672HS

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/03/2019

Event Type  Injury  

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 the procedure, the hcp noticed that there was a burn in right vestibulum nasi during use of handpiece with 70 ° diamond drill while performing draft iib procedure at the right frontal sinus.Drill becomes extremely hot, the cause for this is not known.The burn was allowed to cool down.On follow-up, the surgeon reported that the device being run was a high-speed bur with a handpiece; she feels that the handpiece worked as expected and does not think that there was something wrong with it, it was the bur that overheated.Irrigation was being run at ¿30cc/min during the whole procedure, the bur was being run at 12,000 rpm in forward mode.¿ the patient sustained a second degree burn in the right nostril and is in good overall condition with adequate pain control; no interventions or procedures were required to address the burn.

Manufacturer Narrative

The diamond cutting tip was compacted with biological contaminants which would likely require the user to apply extra pressure to maintain performance.The suction path in the center of the distal end was compacted with biological contaminants indicating that the bur was being pushed into the material.A clogged suction path may lead to buildup of material in the cutting tip.An attempt was made to spin the inner assembly by the inner hub and it would not turn.The tip of the bur was soaked in water for 5 minutes to free up any dried contaminants and the bur spun freely by hand.Functionally, the bur was run at 12,000 rpm for 2 minutes non-stop using 30cc/min as reported by the customer.After the function test, no portion of the bur exceeded 86 degrees fahrenheit.There was no heat discoloration on the outer tube.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8757116
• MDR Text Key: 149911906
• Report Number: 1625507-2019-00058
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

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
• Device Operator: Health Professional
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 97