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

Model Number	1883516HRE
Medical Device Problem Codes	Vibration (1674); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider reported via manufacturer representative that last tuesday the blade was vibrating and making strange noise during sinus surgery.They had to open another blade.There was no patient injury.

• 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: 12547209
• Report Number: 1045254-2021-00543
• Device Sequence Number: 17016081
• Product Code: EQJ
• UDI-Device Identifier: 00885074525167
• UDI-Public: 00885074525167
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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 Expiration Date: 06/22/2025
• Device Model Number: 1883516HRE
• Device Catalogue Number: 1883516HRE
• Device Lot Number: 0222472792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1