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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 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Erratic or Intermittent Display 740 740
No Display/Image 412 412
Display or Visual Feedback Problem 374 374
Break 182 182
Optical Problem 175 175
Poor Quality Image 122 122
Electrical /Electronic Property Problem 68 68
Image Display Error/Artifact 45 45
Connection Problem 45 45
Loose or Intermittent Connection 38 38
Use of Device Problem 24 24
Failure to Power Up 20 20
Insufficient Information 20 20
Appropriate Term/Code Not Available 20 20
Detachment of Device or Device Component 17 17
Output Problem 16 16
Material Fragmentation 15 15
Defective Component 14 14
Defective Device 14 14
Battery Problem 14 14
Intermittent Loss of Power 14 14
Therapeutic or Diagnostic Output Failure 13 13
Optical Obstruction 13 13
Overheating of Device 12 12
Material Separation 11 11
Mechanical Problem 11 11
Failure to Disconnect 10 10
Device Damaged Prior to Use 10 10
Fitting Problem 9 9
Activation Failure 9 9
Power Problem 6 6
Electrical Shorting 6 6
Manufacturing, Packaging or Shipping Problem 6 6
No Visual Prompts/Feedback 6 6
Improper or Incorrect Procedure or Method 6 6
Intermittent Continuity 6 6
Crack 5 5
Fracture 5 5
Display Difficult to Read 5 5
Failure to Run on Battery 5 5
Device-Device Incompatibility 5 5
Device Dislodged or Dislocated 5 5
Environmental Compatibility Problem 4 4
Material Integrity Problem 4 4
Intermittent Energy Output 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Physical Resistance/Sticking 4 4
Sharp Edges 4 4
Temperature Problem 4 4
Energy Output Problem 4 4
Charging Problem 4 4
Component Incompatible 4 4
Disconnection 4 4
Continuous Firing 4 4
Corroded 4 4
Image Orientation Incorrect 3 3
Labelling, Instructions for Use or Training Problem 3 3
Communication or Transmission Problem 3 3
Deformation Due to Compressive Stress 3 3
Component Missing 3 3
Structural Problem 3 3
Off-Label Use 3 3
Product Quality Problem 3 3
Unexpected Shutdown 3 3
Activation Problem 3 3
Mechanical Jam 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Battery Problem: Low Impedance 2 2
Scratched Material 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Material Deformation 2 2
Human-Device Interface Problem 2 2
Improper Chemical Reaction 2 2
Inadequate User Interface 2 2
Electrical Power Problem 2 2
Failure to Clean Adequately 2 2
No Apparent Adverse Event 2 2
Incomplete or Inadequate Connection 2 2
Intermittent Communication Failure 2 2
Smoking 2 2
Peeled/Delaminated 2 2
Vibration 2 2
Flaked 2 2
Loss of or Failure to Bond 2 2
Premature Discharge of Battery 1 1
Failure to Charge 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Material Discolored 1 1
Electromagnetic Interference 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
Visual Prompts will not Clear 1 1
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1173 1173
No Consequences Or Impact To Patient 476 476
Insufficient Information 180 180
No Known Impact Or Consequence To Patient 126 126
No Patient Involvement 112 112
Unspecified Tissue Injury 16 16
Low Oxygen Saturation 14 14
Cardiac Arrest 11 11
Laceration(s) 11 11
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
Hemorrhage/Bleeding 6 6
Aspiration/Inhalation 6 6
Death 5 5
Bradycardia 3 3
Abrasion 3 3
Hypoxia 3 3
Sore Throat 3 3
Tooth Fracture 3 3
Unspecified Respiratory Problem 3 3
Respiratory Arrest 2 2
No Code Available 2 2
Missing Value Reason 2 2
Device Embedded In Tissue or Plaque 2 2
Tissue Damage 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
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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