MAUDE Adverse Event Report: Medtronic Xomed Inc. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884006
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, it was discovered that the blade could not make the cut.The procedure was completed with backup product.There was no patient injury.
Additional Manufacturer Narrative
H3: the device and an open pouch were returned in a resealable bag within a large plastic sleeve.Upon receipt, the pouch was open on three of its four sides.Visual examination of the device revealed traces of contamination on the inner shaft tip and at the proximal end of the inner shaft.No damage was noted to the outer tube or the inner and outer hubs.However, it was observed that the area of the shaft located between the inner and outer hubs was slightly bent.The inner assembly rotated by hand without binding.The device was loaded into a handpiece and oscillated up to 5,000 rpm, resulting in wobbling.The device was able to cut through chicken tissue, but with difficulty due to the wobbling.The device failed due to the defective condition upon return and the inability to cut and rotate properly.In the returned condition, the inner shaft was found to be bent, and the device was wobbling; therefore, the complaint was confirmed.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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50910716
• Report Number: 1045254-2026-01309
• Device Sequence Number: 17475411
• Product Code: EQJ
• UDI-Device Identifier: 00763000518134
• UDI-Public: (01)00763000518134(17)330909(10)0232258350
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 1884006
• Device Catalogue Number: 1884006
• Device Lot Number: 0232258350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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