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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
Product CodeCAL
Regulation Number 868.5530
Device Class 1

MDR Year MDR Reports MDR Events
2014 21 21
2015 4 4
2016 7 7
2017 10 10
2018 4 4
2019 1 1
2020 2 2
2021 60 60
2022 258 258
2023 268 268
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 311 311
Fluid/Blood Leak 204 204
Loose or Intermittent Connection 74 74
Obstruction of Flow 11 11
Battery Problem 9 9
Material Fragmentation 7 7
Device Reprocessing Problem 6 6
Optical Distortion 6 6
Optical Problem 5 5
No Display/Image 5 5
Activation, Positioning or Separation Problem 5 5
Microbial Contamination of Device 4 4
Poor Quality Image 4 4
Failure to Conduct 4 4
Nonstandard Device 3 3
Material Separation 3 3
Metal Shedding Debris 3 3
Overcorrection 3 3
Material Integrity Problem 2 2
Difficult to Remove 2 2
Detachment of Device or Device Component 2 2
Detachment Of Device Component 2 2
Flaked 2 2
Difficult to Insert 2 2
Kinked 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Material Frayed 1 1
Fracture 1 1
Air Leak 1 1
Display or Visual Feedback Problem 1 1
Fire 1 1
Positioning Failure 1 1
Erratic or Intermittent Display 1 1
Device Operates Differently Than Expected 1 1
Inadequate Lighting 1 1
Material Deformation 1 1
Component Missing 1 1
Residue After Decontamination 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Failure to Select Signal 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Overheating of Device 1 1
No Fail-Safe Mechanism 1 1
Delamination 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Failure to Clean Adequately 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 632 632
No Consequences Or Impact To Patient 15 15
No Patient Involvement 12 12
Insufficient Information 9 9
No Information 5 5
No Known Impact Or Consequence To Patient 5 5
Patient Problem/Medical Problem 4 4
Respiratory Tract Infection 3 3
Bacterial Infection 3 3
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Anoxia 1 1
Sleep Dysfunction 1 1
Blood Loss 1 1
Death 1 1
Inflammation 1 1
Pain 1 1
Weakness 1 1
Sneezing 1 1
Injury 1 1
Sore Throat 1 1
No Code Available 1 1
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
3 Karl Storz Endoscopy America Inc II Dec-17-2013
4 Pentax Medical Company II Jun-28-2016
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