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TPLC
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Device
endoscopic access overtube, gastroenterology-urology
Definition
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Product Code
FED
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
BODDINGTONS PLASTICS LTD
SUBSTANTIALLY EQUIVALENT
1
CALYXO, INC.
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
DORNIER MEDTECH AMERICA INC
SUBSTANTIALLY EQUIVALENT
1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
H&A MUI ENTERPRISES INC.
SUBSTANTIALLY EQUIVALENT
1
KALERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K200419
Kalera Vacuum Aspiration Catheter (K-VAC)
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NEPTUNE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
SUMITOMO BAKELITE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SUZHOU BEYO MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TROKAMED GMBH
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
30
30
2020
33
33
2021
55
55
2022
36
36
2023
53
53
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Peeled/Delaminated
36
36
Material Split, Cut or Torn
26
26
Material Integrity Problem
18
18
Break
18
18
Adverse Event Without Identified Device or Use Problem
17
17
Flaked
11
11
Unsealed Device Packaging
10
10
Difficult to Insert
9
9
Difficult to Advance
9
9
Device Contamination with Chemical or Other Material
8
8
Misassembled
7
7
Detachment of Device or Device Component
6
6
Material Deformation
5
5
Accessory Incompatible
5
5
Complete Blockage
5
5
Material Fragmentation
4
4
Material Frayed
4
4
Inflation Problem
4
4
Tear, Rip or Hole in Device Packaging
4
4
Material Separation
4
4
Device Contaminated During Manufacture or Shipping
4
4
Defective Device
4
4
Material Twisted/Bent
3
3
Insufficient Information
3
3
Difficult to Remove
3
3
Unraveled Material
3
3
Separation Failure
2
2
Shipping Damage or Problem
2
2
Nonstandard Device
2
2
Contamination
2
2
Crack
2
2
Disconnection
2
2
Partial Blockage
2
2
Scratched Material
2
2
Packaging Problem
2
2
Contamination /Decontamination Problem
2
2
Patient-Device Incompatibility
1
1
Device Damaged by Another Device
1
1
Device-Device Incompatibility
1
1
Positioning Problem
1
1
Material Protrusion/Extrusion
1
1
Device Handling Problem
1
1
Physical Resistance/Sticking
1
1
Suction Failure
1
1
Separation Problem
1
1
Premature Separation
1
1
Failure to Deflate
1
1
Unintended Deflation
1
1
Burst Container or Vessel
1
1
Material Disintegration
1
1
Inability to Irrigate
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Material Too Rigid or Stiff
1
1
Device Difficult to Setup or Prepare
1
1
Material Puncture/Hole
1
1
Structural Problem
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
121
121
No Consequences Or Impact To Patient
41
41
No Known Impact Or Consequence To Patient
21
21
Insufficient Information
12
12
Foreign Body In Patient
9
9
Perforation
7
7
No Patient Involvement
5
5
No Information
4
4
Injury
3
3
Hemorrhage/Bleeding
3
3
Laceration(s)
2
2
Perforation of Esophagus
2
2
Tissue Damage
2
2
Patient Problem/Medical Problem
1
1
No Code Available
1
1
Gastrointestinal Hemorrhage
1
1
Easy Bruising
1
1
Unspecified Tissue Injury
1
1
Device Embedded In Tissue or Plaque
1
1
Hematuria
1
1
Blood Loss
1
1
Laceration(s) of Esophagus
1
1
Pneumothorax
1
1
Peritonitis
1
1
Discomfort
1
1
Internal Organ Perforation
1
1
Inflammation
1
1
Air Embolism
1
1
Erosion
1
1
Death
1
1
Fever
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boddingtons Plastics Ltd
II
Apr-16-2020
2
Olympus Corporation of the Americas
II
Sep-03-2021
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