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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 31181098E
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
A device evaluation is not available. The product was not returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a bilateral cochlear procedure, the visao curved bur tip broke off inside of a patient and migrated into the patient vestibule. As a result, the surgeon attempted to "drill out" [enlarge] the area identified by imaging to retrieve the fragment. Reports indicate that the patient left the or with the "retained item. ".
 
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Brand NameXPS® BUR
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer Contact
uriza shums
6743 southpoint drive north
jacksonville, FL 32216
9043328405
MDR Report Key7396144
MDR Text Key104359188
Report Number1045254-2018-00151
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
Type of Report Initial
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/19/2021
Device Model Number31181098E
Device Catalogue Number31181098E
Device Lot Number0212993888
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 Received03/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/20/2017
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: 04/04/2018 Patient Sequence Number: 1
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