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TPLC
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show TPLC since
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Device
laryngoscope, rigid
Product Code
CCW
Regulation Number
868.5540
Device Class
1
Premarket Reviews
Manufacturer
Decision
GIRGIS SCOPE LLC
SUBSTANTIALLY EQUIVALENT
1
1. K163412
Girgis Scope Video 200 Double Bladed Laryngoscope
...
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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