MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number 1885061HS

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Follow-up with the customer indicates that the blade was used at 12,000 rpm with irrigation as well as suction.

Manufacturer Narrative

Follow-up with the customer indicates that the blade was used at 12 ,000 rpm with irrigation as well as suction.G4.The new additional information was received on may 15, 2015.

Event Description

It was reported that during a case, while using the bur with an m5 handpiece, the bur burned the patient's lip.Follow-up with the customer indicates that it was a second degree burn on the nasal floor and lip of the patient.Topical burn medication was administered to prevent infection and improve healing.The customer stated that they were done with the bur at that point so they did not need to replace the bur.The customer alleged the issue was only with the bur.

Manufacturer Narrative

Concomitant products.1899200 ¿ m5 microdebrider; 510k number - k081277.(b)(4).

Manufacturer Narrative

The product analysis was completed on july 6, 2015.(b)(4): the product analysis indicates there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].The distal tip and spiral wrap did not appear to be damaged.The biological contamination was cleaned from the bur.Quality engineer operated the bur using an ipc console and m5 handpiece.The result of the investigation performed indicates that the bur showed no overheating when operated at the recommended speed of 12k rpm.When the bur was operated at 30k, the bur was heating up at an approximate rate of 1c/sec.Temperature as high as 54c (34c originally) was recorded in 15-20 sec.Instructions for use warns customer that burs should not be operated at the speed higher than recommended speed.The bur label clearly states that this bur must be operated at less than 12k rpm.(b)(4): the handpiece was not returned.Therefore a product analysis was not performed.Method: actual device evaluated, visual inspection, labeling evaluation.Results: thermal problem; conclusion: use error caused or contributed to event.

Manufacturer Narrative

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 4765836
• MDR Text Key: 5904030
• Report Number: 3004209178-2015-08957
• Device Sequence Number: 1
• Product Code: EQJ
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2015

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 Expiration Date: 05/27/2022
• Device Model Number: 1885061HS
• Device Catalogue Number: 1885061HS
• Device Lot Number: HG058JM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/06/2015
• Supplement Dates FDA Received: 06/09/2015; 07/09/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00040 YR
• Patient Weight: 52