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TPLC
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Device
laryngoscope, non-rigid
Regulation Description
Flexible laryngoscope.
Product Code
CAL
Regulation Number
868.5530
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
60
60
2022
258
258
2023
268
268
2024
204
204
2025
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
405
405
Fluid/Blood Leak
251
251
Loose or Intermittent Connection
97
97
Obstruction of Flow
14
14
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
Material Split, Cut or Torn
3
3
Overcorrection
3
3
Unintended Movement
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
Optical Obstruction
2
2
Material Frayed
1
1
Leak/Splash
1
1
Mechanical Problem
1
1
Insufficient Information
1
1
Defective Component
1
1
Defective Device
1
1
Failure to Clean Adequately
1
1
Component Missing
1
1
Residue After Decontamination
1
1
Erratic or Intermittent Display
1
1
Fracture
1
1
Unintended System Motion
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
812
812
Insufficient Information
10
10
Patient Problem/Medical Problem
4
4
Foreign Body In Patient
2
2
Respiratory Tract Infection
2
2
Transmissible Spongiform Encephalopathy(TSE)
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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