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TPLC
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show TPLC since
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2024
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Device
laryngoscope, non-rigid
Product Code
CAL
Regulation Number
868.5530
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
1
1
2020
2
2
2021
60
60
2022
258
258
2023
268
268
2024
139
139
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
357
357
Fluid/Blood Leak
227
227
Loose or Intermittent Connection
81
81
Obstruction of Flow
11
11
Optical Distortion
6
6
Material Fragmentation
6
6
No Display/Image
5
5
Optical Problem
5
5
Poor Quality Image
4
4
Detachment of Device or Device Component
4
4
Overcorrection
3
3
Material Separation
3
3
Material Integrity Problem
2
2
Microbial Contamination of Device
2
2
Device Reprocessing Problem
2
2
Nonstandard Device
2
2
Leak/Splash
1
1
Material Frayed
1
1
Mechanical Problem
1
1
Failure to Clean Adequately
1
1
Defective Component
1
1
Defective Device
1
1
Flaked
1
1
Unintended Movement
1
1
Insufficient Information
1
1
Component Missing
1
1
Residue After Decontamination
1
1
Fracture
1
1
Erratic or Intermittent Display
1
1
Inaccurate Information
1
1
Unintended System Motion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
711
711
Insufficient Information
9
9
Patient Problem/Medical Problem
4
4
Foreign Body In Patient
2
2
Respiratory Tract Infection
2
2
Transmissible Spongiform Encephalopathy(TSE)
1
1
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
II
Oct-29-2021
2
Karl Storz Endoscopy
II
Aug-27-2020
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