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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
SONOSCAPE MEDICAL CORP
SUBSTANTIALLY EQUIVALENT
1
SONOSCAPE MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
3
3
2020
823
823
2021
1453
1453
2022
1828
1828
2023
2182
2182
2024
349
350
Device Problems
MDRs with this Device Problem
Events in those MDRs
Communication or Transmission Problem
1825
1826
Electrical /Electronic Property Problem
1075
1075
No Display/Image
492
492
Failure to Power Up
424
424
Output Problem
327
327
Display or Visual Feedback Problem
304
304
Break
242
242
No Device Output
226
226
Poor Quality Image
203
203
Power Problem
186
186
Connection Problem
163
163
Defective Component
152
152
No Visual Prompts/Feedback
145
145
Optical Problem
130
130
Erratic or Intermittent Display
107
107
Image Display Error/Artifact
97
97
Key or Button Unresponsive/not Working
89
89
Mechanical Problem
82
82
Loss of Power
57
57
Defective Device
52
52
Overheating of Device
50
50
Loose or Intermittent Connection
49
49
Intermittent Loss of Power
46
46
Leak/Splash
44
44
Detachment of Device or Device Component
42
42
Electrical Power Problem
37
37
Unexpected Shutdown
35
35
Physical Resistance/Sticking
32
32
Temperature Problem
28
28
Fluid/Blood Leak
27
27
Noise, Audible
25
25
Corroded
24
24
Energy Output Problem
20
20
Application Program Problem
19
19
Mechanical Jam
18
18
Crack
18
18
Intermittent Communication Failure
17
17
Device Alarm System
16
16
Material Integrity Problem
16
16
Flare or Flash
15
15
Use of Device Problem
15
15
Appropriate Term/Code Not Available
15
15
Component Missing
13
13
Adverse Event Without Identified Device or Use Problem
13
13
Contamination
12
12
Failure to Clean Adequately
12
12
Smoking
11
11
Output below Specifications
10
10
Installation-Related Problem
10
10
Circuit Failure
10
10
Moisture Damage
10
10
Insufficient Cooling
9
9
Unintended Power Up
9
9
Contamination /Decontamination Problem
9
9
Moisture or Humidity Problem
8
8
Thermal Decomposition of Device
8
8
Excessive Heating
8
8
Fracture
7
7
Component or Accessory Incompatibility
7
7
Sparking
7
7
Electrical Shorting
6
6
Device Contamination with Chemical or Other Material
6
6
Display Difficult to Read
6
6
Degraded
5
5
Naturally Worn
5
5
Incomplete or Inadequate Connection
5
5
Separation Problem
5
5
Air/Gas in Device
5
5
Poor Visibility
5
5
Material Split, Cut or Torn
4
4
Unintended Movement
4
4
Gas/Air Leak
4
4
Infusion or Flow Problem
4
4
Material Deformation
4
4
Pressure Problem
4
4
Intermittent Continuity
4
4
Device Reprocessing Problem
4
4
Component Incompatible
4
4
Accessory Incompatible
4
4
Inflation Problem
4
4
Misconnection
4
4
Device Emits Odor
3
3
Peeled/Delaminated
3
3
Disconnection
3
3
Emergency Power Failure
3
3
Entrapment of Device
3
3
Material Twisted/Bent
3
3
Operating System Becomes Nonfunctional
3
3
Failure to Shut Off
3
3
Device Sensing Problem
3
3
Device Markings/Labelling Problem
3
3
Complete Loss of Power
3
3
Activation Problem
2
2
Intermittent Energy Output
2
2
Ventilation Problem in Device Environment
2
2
Misassembly by Users
2
2
Insufficient Information
2
2
Wireless Communication Problem
2
2
Device Handling Problem
2
2
Audible Prompt/Feedback Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5574
5575
No Consequences Or Impact To Patient
738
738
No Patient Involvement
296
296
No Known Impact Or Consequence To Patient
33
33
Foreign Body In Patient
19
19
Burn(s)
9
9
Insufficient Information
8
8
Perforation
6
6
Urinary Tract Infection
4
4
Fever
4
4
Patient Problem/Medical Problem
4
4
Dysuria
4
4
Unspecified Tissue Injury
4
4
Electric Shock
3
3
Device Embedded In Tissue or Plaque
3
3
No Information
2
2
Cough
2
2
Partial thickness (Second Degree) Burn
2
2
Superficial (First Degree) Burn
2
2
Adult Respiratory Distress Syndrome
2
2
Airway Obstruction
2
2
Aspiration/Inhalation
2
2
Injury
2
2
Perforation of Esophagus
2
2
Burn, Thermal
1
1
Rupture
1
1
Discomfort
1
1
Abdominal Pain
1
1
Sepsis
1
1
Bowel Burn
1
1
Arrhythmia
1
1
Hemorrhage/Bleeding
1
1
Pain
1
1
Abdominal Distention
1
1
Bowel Perforation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unspecified Respiratory Problem
1
1
Unspecified Hepatic or Biliary Problem
1
1
Blister
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
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