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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT
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MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1882969
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The healthcare provider (hcp) reported that the bur broke within 30 seconds and just spun in the handpiece.The second bur broke towards the end of the case and actually came off in the patient and was retrieved with a forcep.There was no injury to the patient but it just stopped spinning and the shaft was fragmented.This is not the first time the burs have snapped but it was the first time one broke off.
 
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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 Key8517956
Report Number1045254-2019-00191
Device Sequence Number1303595
Product Code EQJ
UDI-Device Identifier00681490613279
UDI-Public00681490613279
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1882969
Device Catalogue Number1882969
Device Lot Number0216929117
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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