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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
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event Serious Injury
Additional 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 or Problem 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 Name
XPS® BUR
Common Device Name
BUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
MDR Report Key7396144
Report Number1045254-2018-00151
Device Sequence Number16313680
Product Code EQJ
UDI-Device Identifier00885074322216
UDI-Public00885074322216
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/19/2021
Device Model Number31181098E
Device Catalogue Number31181098E
Device Lot Number0212993888
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/07/2018
Initial Report FDA Received Date04/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age1 YR
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