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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT

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MEDTRONIC XOMED INC. MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number XOM UNKNOWN BLADE
Device Problems Break (1069); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider reported that the blade was stuck inside the handpiece after the procedure. The blade broke off. There was no patient impact.
 
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Brand NameMICRODEBRIDER BLADES AND BURS
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
tricha miles
6743 southpoint drive north
jacksonville, FL 32216
7635140379
MDR Report Key10645692
MDR Text Key210478249
Report Number1045254-2020-00455
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K081277
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 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXOM UNKNOWN BLADE
Device Catalogue NumberXOM UNKNOWN BLADE
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 Received10/27/2020
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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