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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - HIGH SPEED RAD®; BUR, EAR, NOSE AND THROAT
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MEDTRONIC XOMED INC. XPS® BUR - HIGH SPEED RAD®; BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1883070HS
Medical Device Problem Codes Break (1069); Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/03/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No analysis possible as the device has not been returned.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A customer reported via a manufacturer representative (rep) that the tip of the blade broke off in the patient's nose.The surgeon was able to retrieve the piece.It was noted that there were no patient symptoms or complications associated with the event.
 
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Brand Name
XPS® BUR - HIGH SPEED RAD®
Common Device Name
BUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key7468415
Report Number1045254-2018-00176
Device Sequence Number173298
Product Code EQJ
UDI-Device Identifier20681490464608
UDI-Public20681490464608
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/27/2018
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 Date08/05/2025
Device Model Number1883070HS
Device Catalogue Number1883070HS
Device Lot Number0213795198
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/03/2018
Initial Report FDA Received Date04/27/2018
Patient Sequence Number1
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