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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS BLADE; BUR, EAR, NOSE AND THROAT
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MEDTRONIC XOMED INC. XPS BLADE; BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1884006
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/11/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A healthcare professional (hcp) reported via manufacturer representative that the distal tip/head and inner cutter of the blade was broken during use in a procedure.There were some fragments that fell off and were removed by grasping forceps.They just started to use the new blade.There was no patient impact.
 
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Brand Name
XPS BLADE
Common Device Name
BUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key12122706
Report Number1045254-2021-00346
Device Sequence Number3490378
Product Code EQJ
UDI-Device Identifier00681490047470
UDI-Public00681490047470
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1884006
Device Catalogue Number1884006
Device Lot Number0221494490
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2021
Initial Report FDA Received Date07/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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