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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
2018 383 383
2019 360 360
2020 496 496
2021 437 437
2022 324 324
2023 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Erratic or Intermittent Display 641 641
No Display/Image 445 445
Optical Problem 222 222
Break 198 198
Display or Visual Feedback Problem 165 165
Poor Quality Image 81 81
Connection Problem 48 48
Image Display Error/Artifact 42 42
Appropriate Term/Code Not Available 38 38
Loose or Intermittent Connection 36 36
Electrical /Electronic Property Problem 31 31
Use of Device Problem 25 25
Detachment of Device or Device Component 22 22
Material Fragmentation 19 19
Insufficient Information 16 16
Battery Problem 15 15
Device Damaged Prior to Use 15 15
Defective Component 15 15
Defective Device 15 15
Overheating of Device 15 15
Failure to Power Up 15 15
Device Operates Differently Than Expected 14 14
Therapeutic or Diagnostic Output Failure 13 13
Intermittent Loss of Power 12 12
Optical Obstruction 12 12
Material Separation 11 11
Failure to Disconnect 10 10
Mechanical Problem 9 9
Output Problem 9 9
Disconnection 7 7
Fitting Problem 7 7
Electrical Shorting 6 6
Physical Resistance/Sticking 6 6
No Visual Prompts/Feedback 6 6
Temperature Problem 5 5
Device Dislodged or Dislocated 5 5
Inadequate Lighting 5 5
Device Inoperable 5 5
Display Difficult to Read 5 5
Corroded 4 4
Crack 4 4
Component Incompatible 4 4
Energy Output Problem 4 4
Fracture 4 4
Improper or Incorrect Procedure or Method 4 4
Component Missing 4 4
Environmental Compatibility Problem 4 4
Charging Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Integrity Problem 4 4
Intermittent Energy Output 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Unexpected Shutdown 3 3
Power Problem 3 3
Communication or Transmission Problem 3 3
Failure to Shut Off 3 3
Failure to Run on Battery 3 3
Product Quality Problem 3 3
Component Falling 3 3
Labelling, Instructions for Use or Training Problem 3 3
Image Orientation Incorrect 3 3
Intermittent Continuity 2 2
Flaked 2 2
Fluid/Blood Leak 2 2
Device Remains Activated 2 2
Loss of Power 2 2
Smoking 2 2
Sticking 2 2
Difficult or Delayed Activation 2 2
Off-Label Use 2 2
Vibration 2 2
Electrical Power Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Material Deformation 2 2
Light Interference 2 2
Battery Problem: Low Impedance 2 2
Incomplete or Inadequate Connection 2 2
Activation Problem 2 2
No Apparent Adverse Event 2 2
Structural Problem 2 2
Scratched Material 2 2
Material Split, Cut or Torn 2 2
Patient Device Interaction Problem 1 1
Separation Problem 1 1
Key or Button Unresponsive/not Working 1 1
Sharp Edges 1 1
Device Fell 1 1
Naturally Worn 1 1
Operating System Becomes Nonfunctional 1 1
Protective Measures Problem 1 1
Positioning Problem 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Flare or Flash 1 1
Human-Device Interface Problem 1 1
Deformation Due to Compressive Stress 1 1
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 792 792
No Consequences Or Impact To Patient 754 754
No Known Impact Or Consequence To Patient 197 197
Insufficient Information 138 138
No Patient Involvement 130 130
Missing Value Reason 21 21
No Information 12 12
Low Oxygen Saturation 11 11
Foreign Body In Patient 10 10
Laceration(s) 10 10
Death 9 9
Injury 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Tissue Injury 7 7
Extubate 7 7
Aspiration/Inhalation 6 6
Cardiac Arrest 6 6
Hypoxia 4 4
Bradycardia 3 3
Sore Throat 3 3
No Code Available 3 3
Tooth Fracture 2 2
Device Embedded In Tissue or Plaque 2 2
Burn(s) 2 2
Abrasion 2 2
Airway Obstruction 2 2
Tissue Damage 2 2
Respiratory Distress 2 2
Shock 1 1
Skin Irritation 1 1
Cardiopulmonary Arrest 1 1
Crushing Injury 1 1
Dyspnea 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 1 1
Partial thickness (Second Degree) Burn 1 1
Obstruction/Occlusion 1 1
Laceration(s) of Esophagus 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Multiple Organ Failure 1 1
Unspecified Respiratory Problem 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 Flexicare Medical Ltd. II Jan-13-2020
3 King Systems Corp. dba Ambu, Inc. I Feb-04-2020
4 Medtronic, PLC II Feb-10-2020
5 TELEFLEX MEDICAL INC II Mar-23-2021
6 TELEFLEX MEDICAL INC II Jul-28-2020
7 TELEFLEX MEDICAL INC II Feb-07-2020
8 Teleflex Medical II Feb-23-2018
9 Verathon, Inc. III Jul-30-2021
10 Verathon, Inc. I Jul-10-2020
11 Verathon, Inc. II Mar-11-2020
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