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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
131
2022
229
229
2023
261
261
2024
368
368
2025
297
297
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
809
809
Vibration
460
460
Physical Resistance/Sticking
104
104
Mechanical Jam
69
69
Material Fragmentation
46
46
Material Separation
42
42
Connection Problem
25
25
Noise, Audible
17
17
Overheating of Device
12
12
Mechanical Problem
10
10
Use of Device Problem
9
9
Material Twisted/Bent
8
8
Device Markings/Labelling Problem
7
7
Output Problem
5
5
Fitting Problem
4
4
Failure to Cut
4
4
Defective Device
3
3
Difficult to Insert
3
3
Dull, Blunt
2
2
Unintended Movement
2
2
Fracture
2
2
Inadequacy of Device Shape and/or Size
2
2
Material Deformation
2
2
No Device Output
1
1
Intermittent Loss of Power
1
1
Failure to Disconnect
1
1
No Apparent Adverse Event
1
1
Detachment of Device or Device Component
1
1
Misconnection
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Mechanics Altered
1
1
Blocked Connection
1
1
Failure to Align
1
1
Failure to Power Up
1
1
Contamination /Decontamination Problem
1
1
Contamination
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Integrity Problem
1
1
Defective Component
1
1
Smoking
1
1
Inability to Irrigate
1
1
Collapse
1
1
Suction Failure
1
1
Crack
1
1
Activation Problem
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1283
1283
No Consequences Or Impact To Patient
66
66
Insufficient Information
20
20
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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