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

Model Number	1884012
Medical Device Problem Codes	Vibration (1674); Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 the blade was connected to the m5 and it wasn¿t cutting when he tried to use it.When the hcp took it out from the patient, the blade was vibrating vigorously.He tried to fix it on again, but it was still vibrating vigorously.Another piece of the blade was opened, but the blade wasn¿t cutting as well.So, the hcp changed the handpiece to m4, and it still wasn¿t cutting as well.He decided to change to another console, after which, the procedure proceeded smoothly.There was no patient injury.
Additional Manufacturer Narrative
Product analysis visually, both the inner shaft and outer tube were bent which would have caused the vibration.The bends were just distal to the assembly¿s hubs which is an indication of bending forces.The tip was in good condition.When viewed under magnification, there was deformation and indentations of the outer hub locking area consistent with aggressive use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9706002
• Report Number: 3004209178-2020-03242
• Device Sequence Number: 14321266
• Product Code: EQJ
• UDI-Device Identifier: 00681490047531
• UDI-Public: 00681490047531
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: HG35TCP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1