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

Model Number	1884002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: analysis results not available; device not received for evaluation.
Event or Problem Description
The physician reported that during a fess the tip of the blade "snapped off in patient".The physician "initially tried to use forceps but could not retrieve the broken piece.Eventually used suction, which worked.No additional procedure was needed."; the fragment was successfully retrieved.There was no patient injury.
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 XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6561485
• Report Number: 1045254-2017-00146
• Device Sequence Number: 13476969
• Product Code: EQJ
• UDI-Device Identifier: 20681490047443
• UDI-Public: 20681490047443
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2024
• Device Model Number: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: HG1GF4G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1