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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC XPS BLADE BUR, EAR, NOSE AND THROAT

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COVIDIEN LLC XPS BLADE BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1883480HRE
Device Problems Vibration (1674); Connection Problem (2900); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported by a health care professional that the blade was unable to seat properly in the handpiece and it whipping around. There was no patient impact. A back up device was used to complete the procedure.
 
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Brand NameXPS BLADE
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer (Section G)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer Contact
david gustafson
6743 southpoint drive north
jacksonville, FL 32216
7635149628
MDR Report Key12052699
MDR Text Key257890920
Report Number9612501-2021-01048
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1883480HRE
Device Catalogue Number1883480HRE
Device Lot Number0221275017
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 Received07/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/02/2020
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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