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

Model Number	1883519HR
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product analysis is not available, the device has not been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the rad blade was broken; no specific details were given, and have been requested.There was no patient impact or injury associated with the malfunction.
Additional Manufacturer Narrative
The completed product analysis confirmed that one opened sample of part number 1883519hr, from lot number 0215252097 was received with a residue consistent with biological contaminants on the device.The reported failure summary was that the blade was broken.Visually, the outer hub came loose from the irrigating collar which would have resulted in the reported event; however, there were no signs of misuse or mishandling.The loose assembly caused a misalignment of the inner and outer assemblies, but no components became detached (no fragments).When viewed under magnification there were trace amounts of a residue consistent with adhesive in the mounting areas.Although it appeared that adhesive was present, the information indicates there was insufficient adhesion to prevent detachment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the rad blade was broken; no specific details were given and have been requested.There was no patient impact or injury associated with the malfunction.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: expiration date updated.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: 7746191
• Report Number: 1045254-2018-00349
• Device Sequence Number: 1085187
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: 0215252097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/11/2018; 10/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1