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TPLC
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Device
endoscope, accessories, narrow band spectrum
Regulation Description
Endoscope and accessories.
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
1. K211882
HD-550 Video Endoscope System
SONOSCAPE MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
823
823
2021
1453
1453
2022
1828
1828
2023
2182
2182
2024
2648
2649
2025
250
250
Device Problems
MDRs with this Device Problem
Events in those MDRs
Communication or Transmission Problem
2502
2503
Electrical /Electronic Property Problem
1097
1097
No Display/Image
837
837
Output Problem
552
552
Failure to Power Up
547
547
Poor Quality Image
508
508
No Device Output
429
429
Display or Visual Feedback Problem
357
357
No Visual Prompts/Feedback
334
334
Break
324
324
Power Problem
213
213
Connection Problem
200
200
Defective Component
172
172
Erratic or Intermittent Display
163
163
Optical Problem
153
153
Image Display Error/Artifact
119
119
Key or Button Unresponsive/not Working
106
106
Mechanical Problem
94
94
Loose or Intermittent Connection
90
90
Leak/Splash
81
81
Loss of Power
66
66
Overheating of Device
62
62
Intermittent Loss of Power
61
61
Defective Device
55
55
Detachment of Device or Device Component
51
51
Electrical Power Problem
48
48
Physical Resistance/Sticking
42
42
Unexpected Shutdown
38
38
Temperature Problem
33
33
Corroded
33
33
Noise, Audible
30
30
Crack
29
29
Fluid/Blood Leak
28
28
Energy Output Problem
23
23
Mechanical Jam
21
21
Flare or Flash
21
21
Material Integrity Problem
21
21
Material Split, Cut or Torn
20
20
Fracture
20
20
Intermittent Communication Failure
19
19
Failure to Clean Adequately
19
19
Application Program Problem
19
19
Activation Problem
18
18
Activation Failure
17
17
Use of Device Problem
17
17
Device Alarm System
17
17
Component Missing
17
17
Appropriate Term/Code Not Available
16
16
Dent in Material
15
15
Moisture Damage
15
15
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8112
8113
No Consequences Or Impact To Patient
737
737
No Patient Involvement
296
296
No Known Impact Or Consequence To Patient
31
31
Foreign Body In Patient
21
21
Insufficient Information
12
12
Burn(s)
9
9
Perforation
9
9
Unspecified Tissue Injury
5
5
Fever
4
4
Dysuria
4
4
Urinary Tract Infection
4
4
Patient Problem/Medical Problem
4
4
Device Embedded In Tissue or Plaque
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Electric Shock
3
3
Perforation of Esophagus
2
2
Aspiration/Inhalation
2
2
Injury
2
2
No Information
2
2
Cough
2
2
Hemorrhage/Bleeding
2
2
Adult Respiratory Distress Syndrome
2
2
Superficial (First Degree) Burn
2
2
Partial thickness (Second Degree) Burn
2
2
Airway Obstruction
2
2
Bowel Perforation
1
1
Pain
1
1
Abdominal Pain
1
1
Abdominal Distention
1
1
Arrhythmia
1
1
Discomfort
1
1
Unspecified Hepatic or Biliary Problem
1
1
Rupture
1
1
Full thickness (Third Degree) Burn
1
1
Unspecified Respiratory Problem
1
1
Burn, Thermal
1
1
Sepsis
1
1
Blister
1
1
Bowel Burn
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
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