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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 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Erratic or Intermittent Display 728 728
No Display/Image 408 408
Display or Visual Feedback Problem 360 360
Break 182 182
Optical Problem 175 175
Poor Quality Image 119 119
Electrical /Electronic Property Problem 58 58
Image Display Error/Artifact 45 45
Connection Problem 45 45
Loose or Intermittent Connection 37 37
Use of Device Problem 24 24
Insufficient Information 20 20
Appropriate Term/Code Not Available 19 19
Failure to Power Up 19 19
Detachment of Device or Device Component 17 17
Material Fragmentation 15 15
Output Problem 15 15
Intermittent Loss of Power 14 14
Defective Device 14 14
Battery Problem 14 14
Defective Component 14 14
Optical Obstruction 13 13
Therapeutic or Diagnostic Output Failure 13 13
Overheating of Device 12 12
Material Separation 10 10
Failure to Disconnect 10 10
Mechanical Problem 10 10
Device Damaged Prior to Use 10 10
Fitting Problem 9 9
Activation Failure 8 8
Power Problem 6 6
Manufacturing, Packaging or Shipping 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
Crack 5 5
Display Difficult to Read 5 5
Device-Device Incompatibility 5 5
Device Dislodged or Dislocated 5 5
Failure to Run on Battery 5 5
Energy Output Problem 4 4
Fracture 4 4
Component Incompatible 4 4
Disconnection 4 4
Continuous Firing 4 4
Corroded 4 4
Intermittent Energy Output 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Physical Resistance/Sticking 4 4
Environmental Compatibility Problem 4 4
Charging Problem 4 4
Material Integrity Problem 4 4
Temperature Problem 4 4
Mechanical Jam 3 3
Communication or Transmission Problem 3 3
Sharp Edges 3 3
Unexpected Shutdown 3 3
Activation Problem 3 3
Image Orientation Incorrect 3 3
Labelling, Instructions for Use or Training Problem 3 3
Component Missing 3 3
Structural Problem 3 3
Deformation Due to Compressive Stress 3 3
Off-Label Use 3 3
Product Quality Problem 3 3
Peeled/Delaminated 2 2
Vibration 2 2
Smoking 2 2
Electrical Power Problem 2 2
Flaked 2 2
Loss of or Failure to Bond 2 2
Incomplete or Inadequate Connection 2 2
Intermittent Communication Failure 2 2
Improper Chemical Reaction 2 2
Inadequate User Interface 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Material Deformation 2 2
Battery Problem: Low Impedance 2 2
Scratched Material 2 2
No Apparent Adverse Event 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Operating System Becomes Nonfunctional 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Naturally Worn 1 1
Infusion or Flow Problem 1 1
Failure to Shut Off 1 1
Flare or Flash 1 1
Human-Device Interface Problem 1 1
Device Fell 1 1
Key or Button Unresponsive/not Working 1 1
Premature Discharge of Battery 1 1
Failure to Charge 1 1
Device Reprocessing Problem 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1142 1142
No Consequences Or Impact To Patient 476 476
Insufficient Information 177 177
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 10 10
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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