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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. XPS® HANDPIECE - VISAO®; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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MEDTRONIC XOMED, INC. XPS® HANDPIECE - VISAO®; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 3334800T
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Preliminary results indicate the temperature test was not performed as the bur could not be inserted.Results of the repair will be recorded once the analysis is available.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The customer reported that the device overheated.There was no patient impact.
 
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Brand Name
XPS® HANDPIECE - VISAO®
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
MEDTRONIC XOMED, INC.
6743 southpoint drive north
jacksonville FL 32216
MDR Report Key7468626
Report Number1045254-2018-00177
Device Sequence Number128031
Product Code ERL
UDI-Device Identifier00885074107349
UDI-Public00885074107349
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K041523
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
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 Model Number3334800T
Device Catalogue Number3334800T
Device Lot Number37117200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/03/2018
Initial Report FDA Received Date04/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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