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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 Separation (1562); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A healthcare professional (hcp) reported that the bur broke in two, the root part of the bur remained and did not detached from the handpiece and the other came off during the ess (endoscopic sinus surgery) procedure. The detached piece seemed to be caught by hospital staff. So, there were no fragments fallen into neither the operating field nor the non-operative field. There was no fragments that got in contact with the patient. There was no troubleshooting done. There was another handpiece that was owned by the hospital and they used it to complete the procedure. There was no impact on neither the patient nor the staff.
 
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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 Key12377387
MDR Text Key268465539
Report Number1045254-2021-00483
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 foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
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

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