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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
2020 496 496
2021 437 437
2022 324 324
2023 346 346
2024 473 473
2025 1038 1038

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 1120 1120
Erratic or Intermittent Display 746 746
Display or Visual Feedback Problem 527 527
Optical Problem 369 369
Poor Quality Image 204 204
Electrical /Electronic Property Problem 113 113
Break 111 111
Device Reprocessing Problem 70 70
Image Display Error/Artifact 54 54
Failure to Power Up 52 52
Use of Device Problem 50 50
Connection Problem 46 46
Mechanical Problem 41 41
Output Problem 41 41
Failure to Run on Battery 40 40
Loose or Intermittent Connection 40 40
Insufficient Information 34 34
Device Handling Problem 23 23
Material Opacification 20 20
Material Erosion 19 19
Detachment of Device or Device Component 17 17
Material Separation 16 16
Appropriate Term/Code Not Available 15 15
Intermittent Loss of Power 14 14
Defective Device 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Therapeutic or Diagnostic Output Failure 13 13
Battery Problem 11 11
Fitting Problem 11 11
Device Damaged Prior to Use 10 10
Activation Failure 10 10
Material Fragmentation 9 9
Temperature Problem 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Material Integrity Problem 8 8
Intermittent Continuity 7 7
Defective Component 7 7
No Visual Prompts/Feedback 7 7
Power Problem 7 7
Mechanical Jam 7 7
Electrical Shorting 6 6
Material Deformation 6 6
Overheating of Device 5 5
Display Difficult to Read 5 5
Crack 5 5
Physical Resistance/Sticking 5 5
Unexpected Shutdown 5 5
Improper or Incorrect Procedure or Method 5 5
Device-Device Incompatibility 5 5
Naturally Worn 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2350 2350
Insufficient Information 363 363
No Consequences Or Impact To Patient 241 241
No Patient Involvement 75 75
No Known Impact Or Consequence To Patient 63 63
Low Oxygen Saturation 19 19
Unspecified Tissue Injury 19 19
Cardiac Arrest 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Laceration(s) 10 10
Foreign Body In Patient 8 8
Hemorrhage/Bleeding 7 7
Unspecified Respiratory Problem 5 5
Aspiration/Inhalation 4 4
Hypoxia 4 4
Bradycardia 4 4
Death 3 3
Airway Obstruction 3 3
Respiratory Arrest 3 3
Tooth Fracture 3 3
Abrasion 3 3
Injury 3 3
Respiratory Insufficiency 2 2
Skin Tears 2 2
Swelling/ Edema 2 2
Burn(s) 2 2
Respiratory Distress 2 2
High Oxygen Saturation 2 2
Vomiting 1 1
Cardiopulmonary Arrest 1 1
Laceration(s) of Esophagus 1 1
Choking 1 1
Pain 1 1
Crushing Injury 1 1
Asystole 1 1
Obstruction/Occlusion 1 1
Exsanguination 1 1
Shock 1 1
Cough 1 1
Perforation 1 1
No Information 1 1
Adult Respiratory Distress Syndrome 1 1
Acoustic Shock 1 1
Extubate 1 1
No Code Available 1 1
Tinnitus 1 1
Sore Throat 1 1
Unintended Extubation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 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 Ltd. II Jan-13-2020
7 Intersurgical Inc I Jul-11-2025
8 Karl Storz Endoscopy II Dec-18-2023
9 King Systems Corp. dba Ambu, Inc. I Feb-04-2020
10 Medtronic, PLC II Feb-10-2020
11 TELEFLEX MEDICAL INC II Mar-23-2021
12 TELEFLEX MEDICAL INC II Jul-28-2020
13 TELEFLEX MEDICAL INC II Feb-07-2020
14 Verathon, Inc. II Jun-04-2024
15 Verathon, Inc. III Jul-30-2021
16 Verathon, Inc. I Jul-10-2020
17 Verathon, Inc. II Mar-11-2020
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