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TPLC
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Device
endoscope, accessories, narrow band spectrum
Definition
Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Product Code
NWB
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
OLYMPUS CORPORATION OF THE AMERICAS
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS WINTER & IBE GMBH
SUBSTANTIALLY EQUIVALENT
1
SONOSCAPE MEDICAL CORP
SUBSTANTIALLY EQUIVALENT
1
SONOSCAPE MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
22
22
2015
32
32
2016
25
25
2017
17
17
2018
4
4
2019
3
3
2020
823
823
2021
1453
1453
2022
1828
1828
2023
2182
2182
2024
1762
1763
Device Problems
MDRs with this Device Problem
Events in those MDRs
Communication or Transmission Problem
2216
2217
Electrical /Electronic Property Problem
1086
1086
No Display/Image
677
677
Failure to Power Up
513
513
Output Problem
452
452
Poor Quality Image
357
357
No Device Output
345
345
Display or Visual Feedback Problem
332
332
Break
289
289
No Visual Prompts/Feedback
272
272
Power Problem
198
198
Connection Problem
184
184
Defective Component
162
162
Optical Problem
141
141
Erratic or Intermittent Display
136
136
Image Display Error/Artifact
111
111
Key or Button Unresponsive/not Working
99
99
Mechanical Problem
87
87
Leak/Splash
68
68
Loose or Intermittent Connection
68
68
Loss of Power
60
60
Overheating of Device
58
58
Defective Device
54
54
Intermittent Loss of Power
52
52
Detachment of Device or Device Component
48
48
Electrical Power Problem
45
45
Physical Resistance/Sticking
38
38
Unexpected Shutdown
37
37
Adverse Event Without Identified Device or Use Problem
31
31
Temperature Problem
31
31
Corroded
30
30
Noise, Audible
30
30
Fluid/Blood Leak
28
28
Crack
26
26
Flare or Flash
20
20
Energy Output Problem
20
20
Mechanical Jam
19
19
Application Program Problem
19
19
Intermittent Communication Failure
18
18
Contamination /Decontamination Problem
18
18
Appropriate Term/Code Not Available
18
18
Component Missing
18
18
Material Integrity Problem
18
18
Use of Device Problem
17
17
Contamination
16
16
Device Alarm System
16
16
Failure to Clean Adequately
16
16
Microbial Contamination of Device
15
15
Device Reprocessing Problem
13
13
Moisture Damage
12
12
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6982
6983
No Consequences Or Impact To Patient
761
761
No Patient Involvement
297
297
No Known Impact Or Consequence To Patient
47
47
Foreign Body In Patient
21
21
Insufficient Information
10
10
Fever
10
10
Burn(s)
10
10
No Information
9
9
Injury
9
9
Perforation
9
9
Unspecified Infection
8
8
Electric Shock
8
8
Bowel Perforation
7
7
Device Embedded In Tissue or Plaque
6
6
Bacterial Infection
6
6
Urinary Tract Infection
5
5
Unspecified Tissue Injury
5
5
Dysuria
4
4
Hemorrhage/Bleeding
4
4
Patient Problem/Medical Problem
4
4
Aspiration/Inhalation
3
3
Chemical Exposure
3
3
Hematoma
3
3
No Code Available
3
3
Pain
3
3
Abdominal Pain
3
3
Abdominal Distention
2
2
Perforation of Esophagus
2
2
Adult Respiratory Distress Syndrome
2
2
Vomiting
2
2
Pneumonia
2
2
Death
2
2
Cough
2
2
Partial thickness (Second Degree) Burn
2
2
Superficial (First Degree) Burn
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Airway Obstruction
2
2
Inflammation
1
1
Burn, Thermal
1
1
Bowel Burn
1
1
Blister
1
1
Rupture
1
1
Sepsis
1
1
Diarrhea
1
1
Cramp(s)
1
1
Septic Shock
1
1
Exposure to Body Fluids
1
1
Chest Pain
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aizu Olympus Co., Ltd.
II
Nov-17-2023
2
Olympus Corporation of the Americas
II
Feb-29-2024
3
Olympus Corporation of the Americas
I
Nov-09-2023
4
Olympus Corporation of the Americas
II
Feb-13-2023
5
Olympus Corporation of the Americas
II
May-19-2022
6
Olympus Corporation of the Americas
II
Mar-12-2019
7
Olympus Corporation of the Americas
II
Feb-24-2017
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