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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
247
247
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
650
650
Vibration
279
279
Material Separation
79
79
Physical Resistance/Sticking
74
74
Material Fragmentation
64
64
Mechanical Jam
43
43
Overheating of Device
20
20
Connection Problem
18
18
Mechanical Problem
12
12
Noise, Audible
11
11
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
Loose or Intermittent Connection
3
3
Fitting Problem
3
3
Defective Device
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Inadequacy of Device Shape and/or Size
2
2
Unintended Movement
2
2
Fracture
2
2
Dull, Blunt
2
2
Intermittent Loss of Power
1
1
Failure to Disconnect
1
1
Contamination
1
1
Activation Problem
1
1
No Device Output
1
1
Blocked Connection
1
1
Failure to Align
1
1
Failure to Power Up
1
1
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Smoking
1
1
Defective Component
1
1
Collapse
1
1
Inability to Irrigate
1
1
No Apparent Adverse Event
1
1
Detachment of Device or Device Component
1
1
Material Deformation
1
1
Misconnection
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
877
877
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
Radiation Exposure, Unintended
7
7
Insufficient Information
7
7
Device Embedded In Tissue or Plaque
7
7
Unspecified Tissue Injury
5
5
Foreign Body In Patient
4
4
Bone Fracture(s)
3
3
Burn(s)
2
2
Oversedation
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
Sep-12-2024
2
Medtronic Xomed, Inc.
II
Oct-21-2021
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