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

Model Number	1882040
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
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 a distributor that at the most beginning of the operation, the doctor noticed that the blade vibrated.The doctor reinstalled the blade but still could not resolve the problem.Another new blade was used to complete the operation.The second blade could function properly without vibration with the same power system.It was the initial use of the blade.The surgery was a inferior turbinate surgery and was delayed for about 5 minutes.There was no error code displayed on the console.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that there was no damage to the tip.Visually, the inner shaft was bent just distal to the inner hub which would have resulted in the reported event.When viewed under magnification, there was damage to the hubs that is consistent with improper of difficulty loading the blade into the handpiece: dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; and locking area deformation caused by the back side of the front collet of the handpiece.Shear or bending forces while loading may bend the shaft.There were no loose components.Even with the deformation of the hubs, functionally, the device loaded securely into a handpiece, ran at 3,000 rpm in oscillate mode/direction, and vibrated as reported.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 XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8317633
• Report Number: 1045254-2019-00070
• Device Sequence Number: 13868863
• Product Code: EQJ
• UDI-Device Identifier: 00681490613286
• UDI-Public: 00681490613286
• 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): 05/10/2019

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: 1882040
• Device Catalogue Number: 1882040
• Device Lot Number: 0215460285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1