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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, rigid
Product CodeCCW
Regulation Number 868.5540
Device Class 1


Premarket Reviews
ManufacturerDecision
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 360 360
2020 496 496
2021 437 437
2022 324 324
2023 347 347
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Erratic or Intermittent Display 703 703
No Display/Image 397 397
Display or Visual Feedback Problem 333 333
Break 182 182
Optical Problem 173 173
Poor Quality Image 113 113
Image Display Error/Artifact 45 45
Electrical /Electronic Property Problem 43 43
Connection Problem 43 43
Loose or Intermittent Connection 36 36
Use of Device Problem 24 24
Failure to Power Up 19 19
Appropriate Term/Code Not Available 19 19
Insufficient Information 18 18
Detachment of Device or Device Component 17 17
Defective Device 14 14
Battery Problem 14 14
Defective Component 14 14
Material Fragmentation 14 14
Intermittent Loss of Power 14 14
Therapeutic or Diagnostic Output Failure 13 13
Optical Obstruction 13 13
Output Problem 12 12
Overheating of Device 12 12
Material Separation 10 10
Failure to Disconnect 10 10
Device Damaged Prior to Use 10 10
Mechanical Problem 10 10
Fitting Problem 9 9
Activation Failure 7 7
Power Problem 6 6
Electrical Shorting 6 6
No Visual Prompts/Feedback 6 6
Improper or Incorrect Procedure or Method 6 6
Intermittent Continuity 6 6
Display Difficult to Read 5 5
Device-Device Incompatibility 5 5
Device Dislodged or Dislocated 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Integrity Problem 4 4
Environmental Compatibility Problem 4 4
Charging Problem 4 4
Temperature Problem 4 4
Intermittent Energy Output 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Physical Resistance/Sticking 4 4
Failure to Run on Battery 4 4
Disconnection 4 4
Component Incompatible 4 4
Continuous Firing 4 4
Corroded 4 4
Crack 4 4
Energy Output Problem 4 4
Fracture 4 4
Image Orientation Incorrect 3 3
Labelling, Instructions for Use or Training Problem 3 3
Off-Label Use 3 3
Product Quality Problem 3 3
Deformation Due to Compressive Stress 3 3
Component Missing 3 3
Structural Problem 3 3
Sharp Edges 3 3
Unexpected Shutdown 3 3
Activation Problem 3 3
Communication or Transmission Problem 3 3
Mechanical Jam 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Material Deformation 2 2
Inadequate User Interface 2 2
No Apparent Adverse Event 2 2
Battery Problem: Low Impedance 2 2
Scratched Material 2 2
Incomplete or Inadequate Connection 2 2
Electrical Power Problem 2 2
Peeled/Delaminated 2 2
Vibration 2 2
Smoking 2 2
Flaked 2 2
Loss of or Failure to Bond 2 2
Electromagnetic Interference 1 1
Material Discolored 1 1
Failure to Charge 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Entrapment of Device 1 1
Fire 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Moisture Damage 1 1
Inadequate or Insufficient Training 1 1
Unstable 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Increase in Pressure 1 1
Loss of Power 1 1
Failure to Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1072 1072
No Consequences Or Impact To Patient 476 476
Insufficient Information 174 174
No Known Impact Or Consequence To Patient 126 126
No Patient Involvement 112 112
Unspecified Tissue Injury 15 15
Low Oxygen Saturation 14 14
Laceration(s) 11 11
Cardiac Arrest 9 9
Foreign Body In Patient 8 8
Injury 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 6 6
Extubate 6 6
Aspiration/Inhalation 6 6
Death 5 5
Hemorrhage/Bleeding 4 4
Bradycardia 3 3
Hypoxia 3 3
Sore Throat 3 3
Tooth Fracture 3 3
Unspecified Respiratory Problem 3 3
No Code Available 2 2
Missing Value Reason 2 2
Device Embedded In Tissue or Plaque 2 2
Tissue Damage 2 2
Abrasion 2 2
Airway Obstruction 2 2
Respiratory Distress 2 2
Shock 1 1
Skin Irritation 1 1
Perforation 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 1 1
Burn(s) 1 1
Dyspnea 1 1
Cardiopulmonary Arrest 1 1
Crushing Injury 1 1
Obstruction/Occlusion 1 1
Laceration(s) of Esophagus 1 1
Choking 1 1
Skin Tears 1 1
Asystole 1 1
Respiratory Arrest 1 1
Unintended Extubation 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-24-2022
2 Covidien I Nov-02-2023
3 Covidien II Nov-01-2023
4 Flexicare Medical Ltd. II Jan-13-2020
5 Karl Storz Endoscopy II Dec-18-2023
6 King Systems Corp. dba Ambu, Inc. I Feb-04-2020
7 Medtronic, PLC II Feb-10-2020
8 TELEFLEX MEDICAL INC II Mar-23-2021
9 TELEFLEX MEDICAL INC II Jul-28-2020
10 TELEFLEX MEDICAL INC II Feb-07-2020
11 Verathon, Inc. III Jul-30-2021
12 Verathon, Inc. I Jul-10-2020
13 Verathon, Inc. II Mar-11-2020
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