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

Model Number 1884012

Device Problems Vibration (1674); Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9706002
• MDR Text Key: 179251175
• Report Number: 3004209178-2020-03242
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490047531
• UDI-Public: 00681490047531
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1