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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® HANDPIECE - UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

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MEDTRONIC XOMED INC. XPS® HANDPIECE - UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) Back to Search Results
Model Number XOM UNKNOWN DRILL
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned. A product analysis has not been performed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported that the drill overheated. The product and serial number are unknown. Requests for additional information have been made. There was no reported patient injury or impact.
 
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Brand NameXPS® HANDPIECE - UNKNOWN
Type of DeviceDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer Contact
uriza shums
6743 southpoint drive north
jacksonville, FL 32216
9043328405
MDR Report Key6945859
MDR Text Key90409374
Report Number1045254-2017-00363
Device Sequence Number1
Product Code HBG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXOM UNKNOWN DRILL
Device Catalogue NumberXOM UNKNOWN DRILL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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