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TPLC
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show TPLC since
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Device
laryngoscope, rigid
Regulation Description
Rigid laryngoscope.
Product Code
CCW
Regulation Number
868.5540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
496
496
2021
437
437
2022
324
324
2023
346
346
2024
473
473
2025
1038
1038
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
1120
1120
Erratic or Intermittent Display
746
746
Display or Visual Feedback Problem
527
527
Optical Problem
369
369
Poor Quality Image
204
204
Electrical /Electronic Property Problem
113
113
Break
111
111
Device Reprocessing Problem
70
70
Image Display Error/Artifact
54
54
Failure to Power Up
52
52
Use of Device Problem
50
50
Connection Problem
46
46
Mechanical Problem
41
41
Output Problem
41
41
Failure to Run on Battery
40
40
Loose or Intermittent Connection
40
40
Insufficient Information
34
34
Device Handling Problem
23
23
Material Opacification
20
20
Material Erosion
19
19
Detachment of Device or Device Component
17
17
Material Separation
16
16
Appropriate Term/Code Not Available
15
15
Intermittent Loss of Power
14
14
Defective Device
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Therapeutic or Diagnostic Output Failure
13
13
Battery Problem
11
11
Fitting Problem
11
11
Device Damaged Prior to Use
10
10
Activation Failure
10
10
Material Fragmentation
9
9
Temperature Problem
9
9
Manufacturing, Packaging or Shipping Problem
8
8
Material Integrity Problem
8
8
Intermittent Continuity
7
7
Defective Component
7
7
No Visual Prompts/Feedback
7
7
Power Problem
7
7
Mechanical Jam
7
7
Electrical Shorting
6
6
Material Deformation
6
6
Overheating of Device
5
5
Display Difficult to Read
5
5
Crack
5
5
Physical Resistance/Sticking
5
5
Unexpected Shutdown
5
5
Improper or Incorrect Procedure or Method
5
5
Device-Device Incompatibility
5
5
Naturally Worn
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2350
2350
Insufficient Information
363
363
No Consequences Or Impact To Patient
241
241
No Patient Involvement
75
75
No Known Impact Or Consequence To Patient
63
63
Low Oxygen Saturation
19
19
Unspecified Tissue Injury
19
19
Cardiac Arrest
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Laceration(s)
10
10
Foreign Body In Patient
8
8
Hemorrhage/Bleeding
7
7
Unspecified Respiratory Problem
5
5
Aspiration/Inhalation
4
4
Hypoxia
4
4
Bradycardia
4
4
Death
3
3
Airway Obstruction
3
3
Respiratory Arrest
3
3
Tooth Fracture
3
3
Abrasion
3
3
Injury
3
3
Respiratory Insufficiency
2
2
Skin Tears
2
2
Swelling/ Edema
2
2
Burn(s)
2
2
Respiratory Distress
2
2
High Oxygen Saturation
2
2
Vomiting
1
1
Cardiopulmonary Arrest
1
1
Laceration(s) of Esophagus
1
1
Choking
1
1
Pain
1
1
Crushing Injury
1
1
Asystole
1
1
Obstruction/Occlusion
1
1
Exsanguination
1
1
Shock
1
1
Cough
1
1
Perforation
1
1
No Information
1
1
Adult Respiratory Distress Syndrome
1
1
Acoustic Shock
1
1
Extubate
1
1
No Code Available
1
1
Tinnitus
1
1
Sore Throat
1
1
Unintended Extubation
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoventilation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Jun-24-2022
2
Covidien
II
Aug-22-2024
3
Covidien
I
Aug-21-2024
4
Covidien
I
Nov-02-2023
5
Covidien
II
Nov-01-2023
6
Flexicare Medical Ltd.
II
Jan-13-2020
7
Intersurgical Inc
I
Jul-11-2025
8
Karl Storz Endoscopy
II
Dec-18-2023
9
King Systems Corp. dba Ambu, Inc.
I
Feb-04-2020
10
Medtronic, PLC
II
Feb-10-2020
11
TELEFLEX MEDICAL INC
II
Mar-23-2021
12
TELEFLEX MEDICAL INC
II
Jul-28-2020
13
TELEFLEX MEDICAL INC
II
Feb-07-2020
14
Verathon, Inc.
II
Jun-04-2024
15
Verathon, Inc.
III
Jul-30-2021
16
Verathon, Inc.
I
Jul-10-2020
17
Verathon, Inc.
II
Mar-11-2020
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