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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 186 186

Device Problems MDRs with this Device Problem Events in those MDRs
Erratic or Intermittent Display 755 755
No Display/Image 421 421
Display or Visual Feedback Problem 392 392
Break 182 182
Optical Problem 175 175
Poor Quality Image 132 132
Electrical /Electronic Property Problem 71 71
Connection Problem 46 46
Image Display Error/Artifact 45 45
Loose or Intermittent Connection 39 39
Use of Device Problem 24 24
Insufficient Information 22 22
Failure to Power Up 21 21
Appropriate Term/Code Not Available 20 20
Detachment of Device or Device Component 17 17
Output Problem 16 16
Material Fragmentation 15 15
Mechanical Problem 14 14
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
Failure to Disconnect 10 10
Device Damaged Prior to Use 10 10
Activation Failure 10 10
Fitting Problem 9 9
Improper or Incorrect Procedure or Method 6 6
Failure to Run on Battery 6 6
Intermittent Continuity 6 6
No Visual Prompts/Feedback 6 6
Power Problem 6 6
Electrical Shorting 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device-Device Incompatibility 5 5
Device Dislodged or Dislocated 5 5
Temperature Problem 5 5
Crack 5 5
Fracture 5 5
Display Difficult to Read 5 5
Component Incompatible 4 4
Disconnection 4 4
Continuous Firing 4 4
Corroded 4 4
Energy Output Problem 4 4
Activation Problem 4 4
Intermittent Energy Output 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Physical Resistance/Sticking 4 4
Sharp Edges 4 4
Environmental Compatibility Problem 4 4
Charging Problem 4 4
Material Integrity Problem 4 4
Mechanical Jam 3 3
Communication or Transmission Problem 3 3
Unexpected Shutdown 3 3
Off-Label Use 3 3
Product Quality Problem 3 3
Component Missing 3 3
Structural Problem 3 3
Deformation Due to Compressive Stress 3 3
Image Orientation Incorrect 3 3
Labelling, Instructions for Use or Training Problem 3 3
Flaked 2 2
Loss of or Failure to Bond 2 2
Vibration 2 2
Smoking 2 2
Peeled/Delaminated 2 2
Incomplete or Inadequate Connection 2 2
Intermittent Communication Failure 2 2
Failure to Clean Adequately 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
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Battery Problem: Low Impedance 2 2
Scratched Material 2 2
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Positioning Problem 1 1
Operating System Becomes Nonfunctional 1 1
Naturally Worn 1 1
Failure to Shut Off 1 1
Flare or Flash 1 1
Infusion or Flow Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Fell 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Device Handling Problem 1 1
No Device Output 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1221 1221
No Consequences Or Impact To Patient 476 476
Insufficient Information 182 182
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 12 12
Laceration(s) 12 12
Foreign Body In Patient 9 9
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
Tooth Fracture 3 3
Sore Throat 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
Respiratory Arrest 2 2
Respiratory Distress 2 2
Shock 2 2
Airway Obstruction 2 2
Burn(s) 2 2
Acoustic Shock 1 1
Dyspnea 1 1
Cardiopulmonary Arrest 1 1
Crushing Injury 1 1
Perforation 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 1 1
Skin Irritation 1 1
Tinnitus 1 1
Laceration(s) of Esophagus 1 1
Choking 1 1
Obstruction/Occlusion 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. II Jun-04-2024
12 Verathon, Inc. III Jul-30-2021
13 Verathon, Inc. I Jul-10-2020
14 Verathon, Inc. II Mar-11-2020
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