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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeFED
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
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
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  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 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 36 36
Material Split, Cut or Torn 26 26
Adverse Event Without Identified Device or Use Problem 23 23
Material Integrity Problem 19 19
Break 18 18
Flaked 11 11
Unsealed Device Packaging 11 11
Difficult to Insert 10 10
Difficult to Advance 9 9
Device Contamination with Chemical or Other Material 9 9
Detachment of Device or Device Component 8 8
Misassembled 7 7
Tear, Rip or Hole in Device Packaging 7 7
Device Contaminated During Manufacture or Shipping 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
Material Separation 4 4
Defective Device 4 4
Device-Device Incompatibility 3 3
Material Twisted/Bent 3 3
Insufficient Information 3 3
Difficult to Remove 3 3
Unraveled Material 3 3
Inability to Irrigate 3 3
Partial Blockage 3 3
Contamination 2 2
Crack 2 2
Disconnection 2 2
Nonstandard Device 2 2
Restricted Flow rate 2 2
Separation Failure 2 2
Shipping Damage or Problem 2 2
Scratched Material 2 2
Packaging Problem 2 2
Material Protrusion/Extrusion 2 2
Contamination /Decontamination Problem 2 2
Improper Chemical Reaction 1 1
Patient-Device Incompatibility 1 1
Device Damaged by Another Device 1 1
Positioning Problem 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
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
Device Contamination with Body Fluid 1 1
Material Disintegration 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 136 136
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 9 9
Hemorrhage/Bleeding 7 7
No Patient Involvement 5 5
Respiratory Failure 4 4
Cardiac Arrest 4 4
No Information 4 4
Unspecified Tissue Injury 3 3
Laceration(s) 3 3
Injury 3 3
Septic Shock 3 3
Tissue Damage 2 2
Rupture 2 2
Perforation of Esophagus 2 2
Hematuria 2 2
Ascites 2 2
Necrosis 2 2
Ischemia 2 2
Aneurysm 2 2
Hypoxia 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Increased Intra-Peritoneal Volume (IIPV) 2 2
Unspecified Kidney or Urinary Problem 2 2
Thrombosis/Thrombus 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 1 1
Patient Problem/Medical Problem 1 1
Gastrointestinal Hemorrhage 1 1
No Code Available 1 1
Easy Bruising 1 1
Fever 1 1
Inflammation 1 1
Erosion 1 1
Death 1 1
Air Embolism 1 1
Pneumothorax 1 1
Internal Organ Perforation 1 1
Pain 1 1
Blood Loss 1 1
Laceration(s) of Esophagus 1 1
Peritonitis 1 1
Discomfort 1 1
Urinary Retention 1 1
Shock 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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