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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. XPS® BUR BUR, EAR, NOSE AND THROAT

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MEDTRONIC XOMED, INC. XPS® BUR BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 31151098E
Device Problem Material Fragmentation (1261)
Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider (hcp) reported that a handpiece bur broke off into a patient during a functional endoscopic sinus surgery (fess). There was no patient injury however there was a delay in concluding the case due to x-ray was called in to find the missing piece but was not found.
 
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Brand NameXPS® BUR
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED, INC.
jacksonville
Manufacturer (Section G)
MEDTRONIC XOMED, INC.
jacksonville
Manufacturer Contact
christy cain
6743 southpoint drive north
jacksonville, FL 32216
9043328353
MDR Report Key9098380
MDR Text Key159375942
Report Number1045254-2019-00466
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31151098E
Device Catalogue Number31151098E
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 Received08/27/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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