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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
264
264
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Reprocessing Problem
768
768
Break
677
677
Connection Problem
259
259
Crack
242
242
Detachment of Device or Device Component
121
121
Adverse Event Without Identified Device or Use Problem
108
108
Mechanical Problem
81
81
Microbial Contamination of Device
77
77
Improper or Incorrect Procedure or Method
76
76
Leak/Splash
74
74
Use of Device Problem
72
72
Failure to Clean Adequately
57
57
Contamination
54
54
Insufficient Information
52
52
Fluid/Blood Leak
47
47
Failure to Disinfect
41
41
Device Handling Problem
41
41
Disconnection
35
35
Device Contamination with Chemical or Other Material
33
33
Component Missing
32
32
Contamination /Decontamination Problem
32
32
Fracture
30
30
Off-Label Use
27
27
Loose or Intermittent Connection
25
25
Fumes or Vapors
22
22
Material Integrity Problem
22
22
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
Use of Incorrect Control/Treatment Settings
15
15
Smoking
14
14
Restricted Flow rate
13
13
Device Operates Differently Than Expected
13
13
Output Problem
13
13
Maintenance Does Not Comply To Manufacturers Recommendations
12
12
Degraded
12
12
Device Alarm System
12
12
Defective Component
11
11
Chemical Problem
10
10
Electrical /Electronic Property Problem
10
10
Incomplete or Inadequate Connection
10
10
Material Split, Cut or Torn
9
9
Filling Problem
9
9
Chemical Spillage
9
9
Residue After Decontamination
9
9
Infusion or Flow Problem
9
9
No Flow
9
9
Mechanical Jam
8
8
Device Disinfection Or Sterilization Issue
8
8
Filtration Problem
8
8
Obstruction of Flow
8
8
Display or Visual Feedback Problem
8
8
Particulates
7
7
Misconnection
7
7
Communication or Transmission Problem
7
7
Device Displays Incorrect Message
6
6
Material Separation
6
6
Fire
6
6
Separation Problem
6
6
Device Difficult to Maintain
6
6
Ventilation Problem in Device Environment
5
5
Protective Measures Problem
5
5
Failure to Cycle
5
5
Device Emits Odor
5
5
Flushing Problem
5
5
Material Fragmentation
5
5
Facilities Issue
5
5
Human-Device Interface Problem
5
5
Manufacturing, Packaging or Shipping Problem
4
4
Material Deformation
4
4
Lack of Maintenance Documentation or Guidelines
4
4
Difficult to Open or Close
4
4
Contamination of Device Ingredient or Reagent
4
4
Shipping Damage or Problem
4
4
Inadequate or Insufficient Training
4
4
False Alarm
4
4
Component Falling
4
4
Component Incompatible
3
3
Accessory Incompatible
3
3
Detachment Of Device Component
3
3
Image Display Error/Artifact
3
3
Labelling, Instructions for Use or Training Problem
3
3
Decrease in Pressure
3
3
Fitting Problem
3
3
Inadequate Filtration Process
3
3
Device Contamination With Biological Material
3
3
Programming Issue
3
3
Pressure Problem
2
2
Unintended Movement
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Device Sensing Problem
2
2
Electrical Shorting
2
2
Improper Flow or Infusion
2
2
Device Rinsing Issue
2
2
Expiration Date Error
2
2
Device Damaged Prior to Use
2
2
Component or Accessory Incompatibility
2
2
Device Difficult to Setup or Prepare
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2244
2244
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
33
33
No Code Available
28
28
Headache
26
26
Burn(s)
23
23
Unspecified Infection
19
19
Death
18
18
Exposure to Body Fluids
13
13
Pain
10
10
Complaint, Ill-Defined
9
9
Burning Sensation
8
8
Fungal Infection
8
8
Bacterial Infection
8
8
Fever
8
8
Skin Discoloration
7
7
Nausea
7
7
Itching Sensation
6
6
Respiratory Distress
6
6
Foreign Body In Patient
6
6
Chills
6
6
Dizziness
6
6
Sneezing
6
6
Urinary Frequency
5
5
Viral Infection
5
5
Caustic/Chemical Burns
5
5
Skin Irritation
5
5
Urinary Tract Infection
5
5
Irritation
5
5
Inflammation
4
4
Dyspnea
4
4
Eye Burn
4
4
Injury
4
4
Eye Pain
4
4
Sexually Transmitted Infection
4
4
Skin Inflammation/ Irritation
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Sore Throat
3
3
Discomfort
3
3
Swelling
3
3
Chest Tightness/Pressure
3
3
Patient Problem/Medical Problem
3
3
Aspiration Pneumonitis
2
2
Electric Shock
2
2
Blood Loss
2
2
Tingling
2
2
Toxicity
2
2
Erythema
2
2
Eye Injury
2
2
Abrasion
2
2
Hepatitis
2
2
Vomiting
2
2
Drug Resistant Bacterial Infection
2
2
Unspecified Respiratory Problem
2
2
Unspecified Eye / Vision Problem
2
2
Test Result
1
1
Sprain
1
1
Scarring
1
1
Perforation
1
1
Rash
1
1
Hypersensitivity/Allergic reaction
1
1
Laceration(s)
1
1
Anaphylactic Shock
1
1
Arrhythmia
1
1
Aspiration/Inhalation
1
1
Asthma
1
1
Abdominal Pain
1
1
Bruise/Contusion
1
1
Fall
1
1
Fungus
1
1
Gastritis
1
1
Conjunctivitis
1
1
Reaction
1
1
Malaise
1
1
Pharyngitis
1
1
Discharge
1
1
Infection, Indirect
1
1
Neck Pain
1
1
Cough
1
1
Bowel Perforation
1
1
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
Dec-22-2023
12
Steris Corporation
III
Nov-16-2020
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