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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
2018
204
204
2019
129
129
2020
100
100
2021
131
131
2022
229
229
2023
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
427
427
Material Separation
146
146
Vibration
139
139
Material Fragmentation
93
93
Mechanical Jam
24
24
Overheating of Device
21
21
Physical Resistance/Sticking
16
16
Use of Device Problem
15
15
Connection Problem
12
12
Adverse Event Without Identified Device or Use Problem
10
10
Device Markings/Labelling Problem
9
9
Mechanical Problem
9
9
Noise, Audible
7
7
Contamination /Decontamination Problem
6
6
Output Problem
5
5
Inability to Irrigate
5
5
Material Twisted/Bent
5
5
Unintended Movement
5
5
Loose or Intermittent Connection
3
3
Detachment of Device or Device Component
3
3
Obstruction of Flow
3
3
Defective Device
3
3
Fitting Problem
2
2
Failure to Power Up
2
2
Fracture
2
2
Unstable
2
2
No Apparent Adverse Event
2
2
Intermittent Loss of Power
1
1
Activation Problem
1
1
Self-Activation or Keying
1
1
Inadequacy of Device Shape and/or Size
1
1
Smoking
1
1
Stretched
1
1
Device Inoperable
1
1
Misconnection
1
1
No Device Output
1
1
Complete Blockage
1
1
Crack
1
1
Display or Visual Feedback Problem
1
1
Defective Component
1
1
Dull, Blunt
1
1
Blocked Connection
1
1
Device Operates Differently Than Expected
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
408
408
No Consequences Or Impact To Patient
340
340
No Known Impact Or Consequence To Patient
51
51
No Patient Involvement
21
21
Radiation Exposure, Unintended
10
10
Device Embedded In Tissue or Plaque
7
7
Burn(s)
7
7
Insufficient Information
7
7
Unintended Radiation Exposure
6
6
Foreign Body In Patient
6
6
Abrasion
5
5
Unspecified Tissue Injury
3
3
Bone Fracture(s)
3
3
Hearing Impairment
2
2
Oversedation
2
2
Eye Injury
2
2
Burn, Thermal
1
1
Partial thickness (Second Degree) Burn
1
1
No Information
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Gyrus ACMI, Inc.
II
Mar-20-2018
2
Medtronic Xomed, Inc.
II
Oct-21-2021
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