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Device
accessories, cleaning, for endoscope
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code
FEB
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED STERILIZATION PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
ADVANCED STERILIZATION PRODUCTS (ASP)
SUBSTANTIALLY EQUIVALENT
2
CUSTOM ULTRASONICS
SUBSTANTIALLY EQUIVALENT
1
CUSTOM ULTRASONICS INC.
SUBSTANTIALLY EQUIVALENT
1
CUSTOM ULTRASONICS, INC.
SUBSTANTIALLY EQUIVALENT
1
LANGFORD IC SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDIVATORS INC
SUBSTANTIALLY EQUIVALENT
1
MEDIVATORS INC.
SUBSTANTIALLY EQUIVALENT
2
MEDIVATORS REPROCESSING SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
MINNTECH CORP.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
3
OLYMPUS MEDICAL SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
48
48
2015
92
92
2016
103
103
2017
69
69
2018
88
88
2019
62
62
2020
426
426
2021
575
575
2022
607
607
2023
998
998
2024
647
647
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Reprocessing Problem
842
842
Break
819
819
Connection Problem
299
299
Crack
248
248
Detachment of Device or Device Component
145
145
Adverse Event Without Identified Device or Use Problem
111
111
Microbial Contamination of Device
89
89
Leak/Splash
86
86
Mechanical Problem
83
83
Failure to Clean Adequately
79
79
Improper or Incorrect Procedure or Method
79
79
Use of Device Problem
74
74
Contamination
54
54
Insufficient Information
54
54
Fluid/Blood Leak
47
47
Device Handling Problem
44
44
Failure to Disinfect
43
43
Component Missing
40
40
Disconnection
36
36
Device Contamination with Chemical or Other Material
33
33
Contamination /Decontamination Problem
32
32
Fumes or Vapors
31
31
Fracture
30
30
Off-Label Use
27
27
Loose or Intermittent Connection
25
25
Material Integrity Problem
23
23
Appropriate Term/Code Not Available
22
22
Misassembly During Maintenance/Repair
21
21
No Apparent Adverse Event
19
19
Defective Device
18
18
Device Inoperable
16
16
Incomplete or Inadequate Connection
15
15
Output Problem
15
15
Use of Incorrect Control/Treatment Settings
15
15
Restricted Flow rate
14
14
Smoking
14
14
Device Alarm System
13
13
Device Operates Differently Than Expected
13
13
Defective Component
13
13
Degraded
12
12
Communication or Transmission Problem
12
12
Maintenance Does Not Comply To Manufacturers Recommendations
12
12
Filling Problem
11
11
Material Split, Cut or Torn
11
11
Infusion or Flow Problem
11
11
Electrical /Electronic Property Problem
10
10
Chemical Problem
10
10
Chemical Spillage
9
9
Residue After Decontamination
9
9
No Flow
9
9
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2613
2613
No Patient Involvement
302
302
No Known Impact Or Consequence To Patient
253
253
No Consequences Or Impact To Patient
167
167
Chemical Exposure
101
101
No Information
46
46
Insufficient Information
34
34
Headache
28
28
No Code Available
28
28
Burn(s)
26
26
Unspecified Infection
19
19
Death
18
18
Exposure to Body Fluids
13
13
Pain
11
11
Burning Sensation
10
10
Complaint, Ill-Defined
9
9
Fungal Infection
8
8
Nausea
8
8
Bacterial Infection
8
8
Fever
8
8
Foreign Body In Patient
7
7
Skin Discoloration
7
7
Respiratory Distress
6
6
Dizziness
6
6
Dyspnea
6
6
Itching Sensation
6
6
Sneezing
6
6
Chills
6
6
Skin Irritation
5
5
Urinary Tract Infection
5
5
Urinary Frequency
5
5
Caustic/Chemical Burns
5
5
Viral Infection
5
5
Irritation
5
5
Eye Pain
4
4
Sore Throat
4
4
Inflammation
4
4
Sexually Transmitted Infection
4
4
Vomiting
4
4
Eye Burn
4
4
Injury
4
4
Patient Problem/Medical Problem
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Discomfort
3
3
Swelling
3
3
Chest Tightness/Pressure
3
3
Asthma
3
3
Skin Inflammation/ Irritation
3
3
Hepatitis
2
2
Electric Shock
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Advanced Sterilization Products
II
Jan-09-2017
2
Advanced Sterilization Products
II
Jun-05-2015
3
Advanced Sterilization Products
II
Apr-18-2013
4
Advanced Sterilization Products
II
Apr-15-2013
5
Minntech Corp
II
Aug-12-2010
6
Olympus Corporation of the Americas
II
Feb-07-2024
7
Olympus Corporation of the Americas
II
Aug-23-2023
8
Olympus Corporation of the Americas
II
Aug-04-2023
9
Olympus Corporation of the Americas
II
Feb-11-2022
10
Olympus Corporation of the Americas
II
Oct-19-2016
11
Steris Corporation
II
Aug-08-2024
12
Steris Corporation
II
Dec-22-2023
13
Steris Corporation
III
Nov-16-2020
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