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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 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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