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

Model Number 1883480HRE

Device Problem Vibration (1674)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis found that the inner assembly would spin, and middle would index freely by hand.There was no damage to the tip, however the inner shaft was bent.When viewed under magnification, there was damage to the hub: 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.There were no loose components.Even with the deformation of the hub, functionally, the device loaded securely into a handpiece.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported via a manufacturer representative that when the blade was connected to a handpiece and rotated during an endoscopic sinus surgery (ess) procedure, the blade oscillated.The hcp noted that the blade blurred.The blade was reconnected to another handpiece that belonged to the hospital and used, however the issue was not resolved.After the disposable blade was replaced, the issue was resolved and the procedure was completed without any problem.There was no intervention planned or performed and there was no delay in the procedure as a result of this event.There was no patient impact or injury.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8189471
• MDR Text Key: 131173597
• Report Number: 1045254-2018-00725
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

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
• Device Operator: Health Professional
• Device Model Number: 1883480HRE
• Device Catalogue Number: 1883480HRE
• Device Lot Number: 0215124399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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