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

Model Number	1884012
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that, they are having issues with the 12 degree when on the handle, it wobbles to be specific.The straight one does not.Hcp has tried the 12 degree on multiple handles and reported that it may be the disposables and not the handle, but was not sure.There was no known patient impact.
Additional Manufacturer Narrative
H6: the previously applied ime e2403, fdm b17 and imf f24 are longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information that the blade was checked prior to use and it was vibrating, that was when it was pulled and not used.There was no patient impact.
Additional Manufacturer Narrative
H6: the previously applied fdc d16 longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received that, the handpiece had no issues and the same handpiece was used with a new blade to complete the procedure.

• 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
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 22001008
• Report Number: 1045254-2025-01318
• Device Sequence Number: 7313685
• Product Code: EQJ
• UDI-Device Identifier: 00763000518158
• UDI-Public: (01)00763000518158(17)320918(10)0229730792
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1884012
• Device Catalogue Number: 1884012
• Device Lot Number: 0229730792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 07/15/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/17/2025; 07/23/2025
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown