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

Model Number	1885078HSE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation was performed as the device has not been returned at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional reported through a manufacturer representative (rep) that during case a bur was used and that it appeared that the patient had a burn on their upper lip from where the shaft of the bur was touching the patients face.Corrective measures included the immediate removal of drill and irrigation with cool sterile saline; placement of mupirocin ointment and mepilex over the burn for remainder of case, and daily wound care with bacitracin bid.It was noted that the burn was 2nd degree and they did not believe that the device was reprocessed or re-used.No additional complications were reported or anticipated as a result of the event.Additional information received from the rep indicated that the bur was being held by the analysis team at the facility.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
Event or Problem Description
Additional information received stated that the event occurred when drilling the nasal bones.Medwatch form (b)(4).

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7777071
• Report Number: 1045254-2018-00367
• Device Sequence Number: 19152542
• Product Code: EQJ
• UDI-Device Identifier: 00613994233233
• UDI-Public: 00613994233233
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 1885078HSE
• Device Catalogue Number: 1885078HSE
• Device Lot Number: 0214228090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 158