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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, rigid
Regulation Description Rigid laryngoscope.
Product CodeCCW
Regulation Number 868.5540
Device Class 1


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

MDR Year MDR Reports MDR Events
2016 825 825
2017 414 414
2018 383 383
2019 360 360
2020 496 496
2021 160 160

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 977 977
Erratic or Intermittent Display 564 564
Optical Problem 313 313
Break 295 295
Device Damaged Prior to Use 90 90
Connection Problem 49 49
Device Markings/Labelling Problem 40 40
Incorrect Device Or Component Shipped 39 39
Device Operates Differently Than Expected 39 39
Appropriate Term/Code Not Available 36 36
Display or Visual Feedback Problem 33 33
Detachment of Device or Device Component 32 32
Poor Quality Image 31 31
Battery Problem 26 26
Material Fragmentation 24 24
Loose or Intermittent Connection 22 22
Image Display Error/Artifact 21 21
Electrical /Electronic Property Problem 16 16
Overheating of Device 15 15
Failure to Power Up 14 14
Fitting Problem 14 14
Inadequate Lighting 13 13
Crack 12 12
Optical Obstruction 12 12
Defective Component 10 10
Material Separation 9 9
Defective Device 8 8
Failure to Disconnect 8 8
Device Inoperable 8 8
Disconnection 7 7
Power Problem 7 7
Physical Resistance/Sticking 6 6
Charging Problem 6 6
Electrical Shorting 6 6
Therapeutic or Diagnostic Output Failure 6 6
Intermittent Loss of Power 6 6
Temperature Problem 5 5
Device Dislodged or Dislocated 5 5
Component Missing 5 5
Use of Device Problem 5 5
Loss of Power 4 4
Component Incompatible 4 4
Mechanical Problem 4 4
Intermittent Energy Output 4 4
Material Integrity Problem 4 4
Moisture or Humidity Problem 4 4
Component Falling 4 4
Product Quality Problem 4 4
Energy Output Problem 4 4
Material Frayed 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Failure to Shut Off 3 3
Light Interference 3 3
Fracture 3 3
Bent 3 3
Fluid Leak 2 2
Labelling, Instructions for Use or Training Problem 2 2
Smoking 2 2
Nonstandard Device 2 2
Insufficient Information 2 2
Output Problem 2 2
Unexpected Shutdown 2 2
Material Split, Cut or Torn 2 2
Incomplete or Inadequate Connection 2 2
Scratched Material 2 2
Material Deformation 2 2
Improper Device Output 2 2
Detachment Of Device Component 2 2
Display Difficult to Read 2 2
Image Orientation Incorrect 2 2
Image Resolution Poor 2 2
Corroded 2 2
Failure to Run on Battery 2 2
Device Remains Activated 2 2
Material Rupture 2 2
Vibration 2 2
Improper or Incorrect Procedure or Method 2 2
Sticking 2 2
Device Stops Intermittently 2 2
Inadequacy of Device Shape and/or Size 1 1
Failure to Reset 1 1
Increase in Pressure 1 1
Peeled/Delaminated 1 1
Misconnection 1 1
Moisture Damage 1 1
Unintended Collision 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Material Discolored 1 1
Intermittent Continuity 1 1
Entrapment of Device 1 1
Flaked 1 1
Difficult to Insert 1 1
Leak/Splash 1 1
Difficult to Advance 1 1
Difficult or Delayed Activation 1 1
Invalid Sensing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1754 1754
No Patient Involvement 290 290
No Known Impact Or Consequence To Patient 261 261
No Clinical Signs, Symptoms or Conditions 247 247
Insufficient Information 41 41
No Information 30 30
Death 22 22
Missing Value Reason 21 21
Foreign Body In Patient 12 12
Injury 9 9
Extubate 8 8
Low Oxygen Saturation 7 7
Hypoxia 7 7
No Code Available 5 5
Aspiration/Inhalation 5 5
Laceration(s) 4 4
Cardiac Arrest 4 4
Sore Throat 3 3
Device Embedded In Tissue or Plaque 3 3
Tooth Fracture 2 2
Patient Problem/Medical Problem 2 2
Tissue Damage 2 2
Bradycardia 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Cardiopulmonary Arrest 2 2
Dyspnea 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Skin Irritation 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Burn(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Partial thickness (Second Degree) Burn 1 1
Multiple Organ Failure 1 1
Unintended Extubation 1 1
Airway Obstruction 1 1
Shock 1 1
Pleural Effusion 1 1
Vomiting 1 1
Choking 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bomimed II Sep-29-2017
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 II Apr-18-2017
10 Verathon, Inc. I Jul-10-2020
11 Verathon, Inc. II Mar-11-2020
12 Verathon, Inc. I Mar-11-2016
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