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TPLC
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show TPLC since
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Device
bur, ear, nose and throat
Product Code
EQJ
Regulation Number
874.4140
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
129
129
2020
100
100
2021
131
131
2022
229
229
2023
261
261
2024
200
200
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
625
625
Vibration
259
259
Material Separation
79
79
Physical Resistance/Sticking
68
68
Material Fragmentation
62
62
Mechanical Jam
40
40
Overheating of Device
19
19
Connection Problem
17
17
Noise, Audible
11
11
Mechanical Problem
10
10
Device Markings/Labelling Problem
9
9
Use of Device Problem
7
7
Contamination /Decontamination Problem
6
6
Material Twisted/Bent
6
6
Output Problem
5
5
Adverse Event Without Identified Device or Use Problem
3
3
Defective Device
3
3
Fitting Problem
3
3
Loose or Intermittent Connection
3
3
Fracture
2
2
Inadequacy of Device Shape and/or Size
2
2
Dull, Blunt
2
2
Unintended Movement
2
2
No Apparent Adverse Event
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Failure to Align
1
1
Failure to Disconnect
1
1
Blocked Connection
1
1
Detachment of Device or Device Component
1
1
Smoking
1
1
Defective Component
1
1
Misconnection
1
1
No Device Output
1
1
Failure to Power Up
1
1
Inability to Irrigate
1
1
Collapse
1
1
Contamination
1
1
Crack
1
1
Intermittent Loss of Power
1
1
Activation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
830
830
No Consequences Or Impact To Patient
176
176
No Known Impact Or Consequence To Patient
18
18
No Patient Involvement
11
11
Unintended Radiation Exposure
8
8
Insufficient Information
7
7
Radiation Exposure, Unintended
7
7
Device Embedded In Tissue or Plaque
7
7
Unspecified Tissue Injury
5
5
Foreign Body In Patient
3
3
Bone Fracture(s)
3
3
Oversedation
2
2
Burn(s)
2
2
Eye Injury
2
2
Superficial (First Degree) Burn
1
1
Burn, Thermal
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Xomed, Inc.
II
Oct-21-2021
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