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

Model Number	1884008
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device indicated that visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.Functionally, the blade loaded securely into a handpiece, ran at 5000 rpm in oscillate mode with no issues.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.There was no out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional reported via a manufacturer representative that the blade shook during an adenoidectomy surgery.This problem was noticed in the beginning of the operation.The doctor reinstalled the blade but still could not solve the problem.Finally, the doctor used another new blade to complete the operation.It was noted that it was the initial use of the blade.The surgery was delayed for about 5 minutes and no error code was displayed on the console.It was noted that there were no patient symptoms associated with the event.
Additional Manufacturer Narrative
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: 7748404
• Report Number: 3004209178-2018-17397
• Device Sequence Number: 120553
• Product Code: EQJ
• UDI-Device Identifier: 20681490047481
• UDI-Public: 20681490047481
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 07/22/2025
• Device Model Number: 1884008
• Device Catalogue Number: 1884008
• Device Lot Number: HG1YXAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR