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

Model Number 1882569HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned; discarded by user.Therefore a product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported the bur was broken during endoscopic sinus surgery.No fragment fell into the patient's body.The bur was discarded by the customer and will not be returned.The procedure was completed with a back-up product.There was no injury reported as a result of this event.

• 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: angie demo ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328355
• MDR Report Key: 7100374
• MDR Text Key: 94391331
• Report Number: 1045254-2017-00449
• 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: 12/08/2017

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 Expiration Date: 08/06/2021
• Device Model Number: 1882569HS
• Device Catalogue Number: 1882569HS
• Device Lot Number: 0213795196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2017
• 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