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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® SYSTEM NAVIGATED BLADE; BUR, EAR, NOSE AND THROAT
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MEDTRONIC XOMED INC. XPS® SYSTEM NAVIGATED BLADE; BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1884380EM
Medical Device Problem Codes Material Separation (1562); Fitting Problem (2183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/18/2018
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
A healthcare provider (hcp) reported via a manufacturer representative that the hub of the blade that holds the navigation piece was loose and came apart during setup for an endoscopic sinus surgery procedure.A back up device was used.There was no delay with the procedure.There was no patient impact.
 
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Brand Name
XPS® SYSTEM NAVIGATED BLADE
Common Device Name
BUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key7795046
Report Number1045254-2018-00379
Device Sequence Number16466459
Product Code EQJ
UDI-Device Identifier00643169209367
UDI-Public00643169209367
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K130608
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/17/2018
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 Date10/17/2019
Device Model Number1884380EM
Device Catalogue Number1884380EM
Device Lot Number0214220648
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/27/2018
Initial Report FDA Received Date08/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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