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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laryngoscope, rigid
Regulation Description Rigid laryngoscope.
Product CodeCCW
Regulation Number 868.5540
Device Class 1

MDR Year MDR Reports MDR Events
2021 437 440
2022 324 324
2023 346 348
2024 473 474
2025 1579 1579

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 1150 1151
Erratic or Intermittent Display 677 677
Display or Visual Feedback Problem 597 597
Optical Problem 424 425
Poor Quality Image 272 273
Device Reprocessing Problem 180 180
Electrical /Electronic Property Problem 147 147
Break 94 95
Output Problem 76 76
Loose or Intermittent Connection 62 62
Use of Device Problem 53 54
Failure to Power Up 53 55
Image Display Error/Artifact 53 53
Failure to Run on Battery 46 46
Mechanical Problem 44 45
Insufficient Information 37 37
Device Handling Problem 29 29
Material Erosion 23 23
Material Opacification 22 22
Adverse Event Without Identified Device or Use Problem 20 20
Detachment of Device or Device Component 18 18
Mechanical Jam 18 18
Appropriate Term/Code Not Available 17 17
Material Fragmentation 15 15
Activation Failure 14 14
Material Separation 13 13
Connection Problem 13 13
Fitting Problem 11 11
Intermittent Loss of Power 11 11
Therapeutic or Diagnostic Output Failure 11 12
Power Problem 10 10
Intermittent Continuity 10 10
Defective Device 10 11
Temperature Problem 10 10
Device Damaged Prior to Use 9 9
Material Integrity Problem 9 9
Activation Problem 8 8
Battery Problem 8 9
Premature Discharge of Battery 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Physical Resistance/Sticking 7 7
No Visual Prompts/Feedback 7 7
Material Deformation 6 6
Energy Output Problem 5 5
Display Difficult to Read 5 5
Defective Component 5 5
Crack 5 5
Device-Device Incompatibility 5 5
Unexpected Shutdown 5 5
Environmental Compatibility Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2722 2725
Insufficient Information 395 397
Low Oxygen Saturation 24 24
Unspecified Tissue Injury 19 19
Cardiac Arrest 16 17
Laceration(s) 10 10
Hemorrhage/Bleeding 9 9
Foreign Body In Patient 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Unspecified Respiratory Problem 7 7
Bradycardia 4 4
Abrasion 3 3
Respiratory Arrest 3 3
Asystole 3 3
Hypoxia 3 3
Airway Obstruction 3 3
Tooth Fracture 2 2
Burn(s) 2 2
Swelling/ Edema 2 2
Skin Tears 2 2
High Oxygen Saturation 2 2
Loss of consciousness 2 2
Respiratory Insufficiency 2 2
Respiratory Failure 2 2
Low Apgar Score 1 1
Aspiration/Inhalation 1 1
Exsanguination 1 1
Perforation 1 1
Diminished Pulse Pressure 1 1
Crushing Injury 1 1
Laceration(s) of Esophagus 1 1
Obstruction/Occlusion 1 1
Adult Respiratory Distress Syndrome 1 1
Acoustic Shock 1 1
Vomiting 1 1
Hypoventilation 1 1
Cardiopulmonary Arrest 1 1
Pain 1 1
Choking 1 1
Arrhythmia 1 1
Shock 1 1
Cough 1 1
Tinnitus 1 1
Sore Throat 1 1
Low Blood Pressure/ Hypotension 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-24-2022
2 Covidien II Aug-22-2024
3 Covidien I Aug-21-2024
4 Covidien I Nov-02-2023
5 Covidien II Nov-01-2023
6 Flexicare Medical (Dongguan) Ltd. I Aug-01-2025
7 Intersurgical Inc I Jul-11-2025
8 Karl Storz Endoscopy II Dec-18-2023
9 TELEFLEX MEDICAL INC II Mar-23-2021
10 Verathon, Inc. II Jun-04-2024
11 Verathon, Inc. III Jul-30-2021
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