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TPLC
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Device
laryngoscope, rigid
Product Code
CCW
Regulation Number
868.5540
Device Class
1
Premarket Reviews
Manufacturer
Decision
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
1. K191602
APA Oxy Blade
MDR Year
MDR Reports
MDR Events
2019
360
360
2020
496
496
2021
437
437
2022
324
324
2023
347
347
2024
169
169
Device Problems
MDRs with this Device Problem
Events in those MDRs
Erratic or Intermittent Display
747
747
No Display/Image
417
417
Display or Visual Feedback Problem
383
383
Break
182
182
Optical Problem
175
175
Poor Quality Image
128
128
Electrical /Electronic Property Problem
71
71
Connection Problem
46
46
Image Display Error/Artifact
45
45
Loose or Intermittent Connection
38
38
Use of Device Problem
24
24
Failure to Power Up
21
21
Insufficient Information
20
20
Appropriate Term/Code Not Available
20
20
Detachment of Device or Device Component
17
17
Output Problem
16
16
Material Fragmentation
15
15
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
Mechanical Problem
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
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
Failure to Run on Battery
5
5
Energy Output Problem
4
4
Component Incompatible
4
4
Disconnection
4
4
Continuous Firing
4
4
Corroded
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
Image Orientation Incorrect
3
3
Labelling, Instructions for Use or Training Problem
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
Vibration
2
2
Smoking
2
2
Peeled/Delaminated
2
2
Flaked
2
2
Loss of or Failure to Bond
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
Premature Discharge of Battery
1
1
Failure to Charge
1
1
Device Reprocessing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1205
1205
No Consequences Or Impact To Patient
476
476
Insufficient Information
181
181
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)
11
11
Injury
8
8
Foreign Body In Patient
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
No Information
6
6
Extubate
6
6
Aspiration/Inhalation
6
6
Hemorrhage/Bleeding
6
6
Death
5
5
Bradycardia
3
3
Abrasion
3
3
Tooth Fracture
3
3
Sore Throat
3
3
Hypoxia
3
3
Unspecified Respiratory Problem
3
3
Respiratory Arrest
2
2
Device Embedded In Tissue or Plaque
2
2
No Code Available
2
2
Missing Value Reason
2
2
Tissue Damage
2
2
Airway Obstruction
2
2
Burn(s)
2
2
Respiratory Distress
2
2
Shock
2
2
Skin Irritation
1
1
Tinnitus
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoventilation
1
1
Dyspnea
1
1
Cardiopulmonary Arrest
1
1
Crushing Injury
1
1
Perforation
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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