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U.S. Department of Health and Human Services

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

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MEDTRONIC XOMED INC. XPS BUR - UNKNOWN BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number XOM UNK BUR
Device Problems Material Fragmentation (1261); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
Analysis found bur debris inside the handpiece. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider (hcp) reported that the bur cannot be inserted to the handpiece. Foreign material may be mixed in. There was no patient involvement. Analysis of the device confirmed that the bur cannot be inserted all the way in due to bur debris (broken bur) that remained inside the handpiece.
 
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Brand NameXPS BUR - UNKNOWN
Type of DeviceBUR, EAR, NOSE AND THROAT
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
david gustafson
6743 southpoint drive north
jacksonville, FL 32216
7635149628
MDR Report Key12238854
MDR Text Key263860964
Report Number1045254-2021-00404
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXOM UNK BUR
Device Catalogue NumberXOM UNK BUR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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