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TPLC
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Device
bur, ear, nose and throat
Regulation Description
Ear, nose, and throat bur.
Product Code
EQJ
Regulation Number
874.4140
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
100
100
2021
131
133
2022
229
229
2023
261
261
2024
368
368
2025
407
407
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
870
870
Vibration
496
496
Physical Resistance/Sticking
107
107
Mechanical Jam
72
72
Material Fragmentation
53
53
Material Separation
48
48
Connection Problem
27
27
Noise, Audible
19
19
Overheating of Device
13
13
Mechanical Problem
12
12
Failure to Cut
11
11
Use of Device Problem
10
10
Material Twisted/Bent
9
9
Device Markings/Labelling Problem
7
7
Output Problem
5
5
Fitting Problem
4
4
Defective Device
3
5
Unintended Movement
3
3
Difficult to Insert
3
3
Fracture
3
3
Material Deformation
2
2
Inadequacy of Device Shape and/or Size
2
2
Device-Device Incompatibility
2
2
Dull, Blunt
2
2
Smoking
1
1
Defective Component
1
1
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Contamination
1
1
Difficult to Remove
1
1
Contamination /Decontamination Problem
1
1
Failure to Power Up
1
1
Inability to Irrigate
1
1
Failure to Align
1
1
Collapse
1
1
Suction Failure
1
1
Blocked Connection
1
1
Mechanics Altered
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Misconnection
1
1
Crack
1
1
Detachment of Device or Device Component
1
1
Material Protrusion/Extrusion
1
1
No Apparent Adverse Event
1
1
Activation Problem
1
1
Off-Label Use
1
1
Failure to Disconnect
1
1
Intermittent Loss of Power
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1389
1389
No Consequences Or Impact To Patient
66
66
Insufficient Information
26
28
No Patient Involvement
11
11
Unintended Radiation Exposure
9
9
Unspecified Tissue Injury
6
6
Device Embedded In Tissue or Plaque
6
6
No Known Impact Or Consequence To Patient
4
4
Radiation Exposure, Unintended
3
3
Bone Fracture(s)
3
3
Foreign Body In Patient
3
3
Oversedation
2
2
Eye Injury
2
2
Superficial (First Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Xomed, Inc.
II
Sep-12-2024
2
Medtronic Xomed, Inc.
II
Oct-21-2021
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