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

Model Number	1884012
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2019
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 (hcp) reported via distributor that a blade vibrated abnormally after being used for 10 minutes during a functional endoscopic sinus surgery (fess).The doctor reinstalled the blade but still could not resolve the problem.Then, the doctor used another new blade to complete the operation.The second blade could function properly without vibration with the same handpiece.It was the initial use of the blade.No error code was displayed on the console.There was a 10 minute delay.There was no patient impact.
Additional Manufacturer Narrative
Analysis report fount out that visually, there was wear at the cutting tip which likely indicates excess speed, improper mode / direction, or aggressive use.There were no bends in the shafts that would result in a vibration.Functionally, the blade was run at the maximum recommended speed of 5,000 rpm in oscillate mode / direction and there was no vibration or wobble.There was no allegation of a defect prior to use.A review of the global complaint data showed no other complaints for this lot number.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates the device was used exceeding the maximum recommended speed, was used in forward direction vs.Oscillate, or excess pressure was applied during 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: 9156983
• Report Number: 3004209178-2019-19022
• Device Sequence Number: 11374896
• Product Code: EQJ
• UDI-Device Identifier: 00681490047531
• UDI-Public: 00681490047531
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: HG33Q5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1