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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
GIRGIS SCOPE LLC
  SUBSTANTIALLY EQUIVALENT 1
PRODOL MEDITEC LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
YEESCOPE PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 202 202
2015 301 301
2016 825 825
2017 414 414
2018 383 383
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
No Display/Image 1236 1236
Erratic or Intermittent Display 1002 1002
Optical Problem 437 437
Break 428 428
Display or Visual Feedback Problem 364 364
Device Damaged Prior to Use 158 158
Poor Quality Image 125 125
Device Operates Differently Than Expected 77 77
Material Fragmentation 68 68
Electrical /Electronic Property Problem 63 63
Connection Problem 62 62
Fitting Problem 52 52
Detachment of Device or Device Component 49 49
Loose or Intermittent Connection 49 49
Image Display Error/Artifact 47 47
Appropriate Term/Code Not Available 42 42
Device Markings/Labelling Problem 41 41
Incorrect Device Or Component Shipped 39 39
Battery Problem 32 32
Detachment Of Device Component 32 32
Failure to Conduct 31 31
Overheating of Device 30 30
Inadequate Lighting 30 30
Use of Device Problem 27 27
Failure to Power Up 27 27
Insufficient Information 26 26
Material Separation 21 21
Packaging Problem 21 21
Mechanical Problem 19 19
Crack 19 19
Fracture 17 17
Defective Component 17 17
Defective Device 17 17
Power Problem 16 16
Device Stops Intermittently 16 16
Temperature Problem 15 15
Output Problem 15 15
Therapeutic or Diagnostic Output Failure 14 14
Device Inoperable 14 14
Intermittent Loss of Power 14 14
Optical Obstruction 13 13
Difficult to Remove 12 12
Difficult To Position 12 12
Light Interference 10 10
Component Missing 10 10
Failure to Disconnect 10 10
Separation Failure 9 9
Improper or Incorrect Procedure or Method 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Material Frayed 9 9
Disconnection 9 9
Material Integrity Problem 8 8
Mechanical Jam 8 8
Activation, Positioning or Separation Problem 8 8
Activation Failure 8 8
Device Dislodged or Dislocated 7 7
Intermittent Continuity 7 7
Loss of or Failure to Bond 7 7
Bent 6 6
Component Falling 6 6
Product Quality Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Charging Problem 6 6
Device-Device Incompatibility 6 6
Electrical Shorting 6 6
Physical Resistance/Sticking 6 6
No Visual Prompts/Feedback 6 6
Out-Of-Box Failure 5 5
Failure to Run on Battery 5 5
Display Difficult to Read 5 5
Corroded 5 5
Component Incompatible 4 4
Continuous Firing 4 4
Loss of Power 4 4
Energy Output Problem 4 4
Difficult to Insert 4 4
Environmental Compatibility Problem 4 4
Material Protrusion/Extrusion 4 4
Moisture or Humidity Problem 4 4
Structural Problem 4 4
Positioning Problem 4 4
Intermittent Energy Output 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Sharp Edges 3 3
Unexpected Shutdown 3 3
Scratched Material 3 3
Activation Problem 3 3
Failure to Shut Off 3 3
Communication or Transmission Problem 3 3
Deformation Due to Compressive Stress 3 3
Labelling, Instructions for Use or Training Problem 3 3
Peeled/Delaminated 3 3
Off-Label Use 3 3
Smoking 3 3
Image Orientation Incorrect 3 3
Image Resolution Poor 2 2
Fluid/Blood Leak 2 2
Flaked 2 2
Difficult or Delayed Positioning 2 2
Device Reprocessing Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1999 1999
No Clinical Signs, Symptoms or Conditions 1142 1142
No Patient Involvement 547 547
No Known Impact Or Consequence To Patient 323 323
Insufficient Information 177 177
No Information 56 56
Death 26 26
Missing Value Reason 21 21
Low Oxygen Saturation 19 19
Laceration(s) 19 19
Foreign Body In Patient 16 16
Unspecified Tissue Injury 15 15
Hypoxia 14 14
Cardiac Arrest 14 14
Injury 12 12
Extubate 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Code Available 7 7
Aspiration/Inhalation 6 6
Bradycardia 5 5
Hemorrhage/Bleeding 5 5
Burn(s) 4 4
Airway Obstruction 4 4
Cardiopulmonary Arrest 4 4
Blood Loss 4 4
Device Embedded In Tissue or Plaque 3 3
Tooth Fracture 3 3
Unspecified Respiratory Problem 3 3
Sore Throat 3 3
Tissue Damage 3 3
Unknown (for use when the patient's condition is not known) 2 2
Rupture 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Abrasion 2 2
Choking 2 2
Patient Problem/Medical Problem 2 2
Not Applicable 1 1
Partial thickness (Second Degree) Burn 1 1
Obstruction/Occlusion 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Unintended Extubation 1 1
Swelling/ Edema 1 1
Multiple Organ Failure 1 1
Asystole 1 1
Respiratory Arrest 1 1
Contusion 1 1
Crushing Injury 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 1 1
Dyspnea 1 1
Erythema 1 1
Head Injury 1 1
Shock 1 1
Skin Irritation 1 1
Pain 1 1
Perforation 1 1
Pleural Effusion 1 1
Discomfort 1 1
Vomiting 1 1
Laceration(s) of Esophagus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aircraft Medical Limited II Dec-02-2014
2 Baxter Healthcare Corporation II Jun-24-2022
3 Bomimed II Sep-29-2017
4 Covidien I Nov-02-2023
5 Covidien II Nov-01-2023
6 Flexicare Medical Ltd. II Jan-13-2020
7 Karl Storz Endoscopy II Dec-18-2023
8 King Systems Corp. dba Ambu, Inc. I Feb-04-2020
9 Medtronic, PLC II Feb-10-2020
10 Penlon, Ltd. II Mar-18-2012
11 Penlon, Ltd. (Fmly East Healthcare) II Sep-14-2011
12 TELEFLEX MEDICAL INC II Mar-23-2021
13 TELEFLEX MEDICAL INC II Jul-28-2020
14 TELEFLEX MEDICAL INC II Feb-07-2020
15 Teleflex Medical II Feb-23-2018
16 Teleflex Medical II Jul-29-2014
17 Teleflex Medical II Jul-26-2014
18 Teleflex Medical II Nov-20-2013
19 Verathon Inc II Apr-18-2017
20 Verathon, Inc. III Jul-30-2021
21 Verathon, Inc. I Jul-10-2020
22 Verathon, Inc. II Mar-11-2020
23 Verathon, Inc. I Mar-11-2016
24 Verathon, Inc. II Dec-15-2015
25 Verathon, Inc. II Jul-13-2015
26 Verathon, Inc. I Jun-20-2013
27 Verathon, Inc. I Dec-07-2012
28 Vital Signs Colorado Inc. II Feb-02-2011
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