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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, non-rigid
Regulation Description Flexible laryngoscope.
Product CodeCAL
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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