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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 Code Mechanical Jam (2983)
Health Effect - Clinical Code Oversedation (1990)
Date of Event 01/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A healthcare provider (hcp) reported that during a sinus surgery (frontal sinus approach) a bur was stuck in the handpiece and the hcp couldn't change it so they had to stop the surgery and program another surgery for the patient.There was no patient impact.The surgery was extended for 30 minutes.
 
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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 Key9778988
Report Number1045254-2020-00124
Device Sequence Number16322085
Product Code EQJ
UDI-Device Identifier20681490464608
UDI-Public20681490464608
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/09/2025
Device Model Number1883070HS
Device Catalogue Number1883070HS
Device Lot Number0212782053
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date03/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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