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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
APOLLO ENDOSURGERY, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
BARONOVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAROSENSE, INC
  SUBSTANTIALLY EQUIVALENT 2
BODDINGTONS PLASTICS LTD
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C2 THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
CALYXO, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 4
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
CROSPON, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
ENDO-AID, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJINON, INC.
  SUBSTANTIALLY EQUIVALENT 1
H&A MUI ENTERPRISES INC.
  SUBSTANTIALLY EQUIVALENT 1
KALERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFTSCOPE MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMITOMO BAKELITE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU BEYO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TROKAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
VISIONSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 34 34
2015 35 35
2016 29 29
2017 32 32
2018 34 34
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 46 46
Break 44 44
Adverse Event Without Identified Device or Use Problem 36 36
Material Split, Cut or Torn 27 27
Detachment Of Device Component 25 25
Material Integrity Problem 21 21
Device Contamination with Chemical or Other Material 14 14
Torn Material 13 13
Detachment of Device or Device Component 13 13
Flaked 13 13
Insufficient Information 10 10
Unsealed Device Packaging 10 10
Difficult to Advance 9 9
Difficult to Insert 9 9
Misassembled 7 7
Material Separation 7 7
Difficult to Remove 6 6
Inflation Problem 6 6
Material Deformation 6 6
Device Contaminated During Manufacture or Shipping 5 5
Complete Blockage 5 5
Fracture 5 5
Material Fragmentation 5 5
Crack 5 5
Accessory Incompatible 5 5
Partial Blockage 5 5
Component Falling 4 4
Material Frayed 4 4
Device Operates Differently Than Expected 4 4
Improper or Incorrect Procedure or Method 4 4
Defective Device 4 4
Material Perforation 4 4
Component Missing 4 4
Tear, Rip or Hole in Device Packaging 4 4
Patient-Device Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Disconnection 3 3
Unraveled Material 3 3
Use of Device Problem 3 3
Scratched Material 3 3
Packaging Problem 2 2
Positioning Problem 2 2
Shipping Damage or Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Nonstandard Device 2 2
Melted 2 2
Contamination 2 2
Device Handling Problem 2 2
Compatibility Problem 2 2
Structural Problem 2 2
Failure to Advance 2 2
Separation Failure 2 2
Device Damaged by Another Device 2 2
Device Packaging Compromised 1 1
Device-Device Incompatibility 1 1
Device Or Device Fragments Location Unknown 1 1
Sparking 1 1
Fitting Problem 1 1
Physical Resistance 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Delamination 1 1
Flare or Flash 1 1
Material Protrusion/Extrusion 1 1
Deflation Problem 1 1
Degraded 1 1
Burst Container or Vessel 1 1
Material Disintegration 1 1
No Display/Image 1 1
Migration or Expulsion of Device 1 1
Inability to Irrigate 1 1
Loose or Intermittent Connection 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Sticking 1 1
Stretched 1 1
Device Inoperable 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Firing 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

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 107 107
No Known Impact Or Consequence To Patient 56 56
Perforation 25 25
Foreign Body In Patient 17 17
Insufficient Information 12 12
Injury 9 9
Device Embedded In Tissue or Plaque 8 8
No Information 8 8
No Patient Involvement 7 7
Internal Organ Perforation 7 7
No Code Available 5 5
Tissue Damage 5 5
Hemorrhage/Bleeding 5 5
Death 4 4
Perforation of Esophagus 4 4
Bowel Perforation 3 3
Hematuria 2 2
Air Embolism 2 2
Laceration(s) 2 2
Myocardial Infarction 1 1
Pneumothorax 1 1
Sepsis 1 1
Peritonitis 1 1
Stenosis 1 1
Discomfort 1 1
Erosion 1 1
Inflammation 1 1
Exsanguination 1 1
Fever 1 1
Hematoma 1 1
Blood Loss 1 1
Abdominal Distention 1 1
Uterine Perforation 1 1
Chills 1 1
Foreign body, removal of 1 1
Laceration(s) of Esophagus 1 1
Patient Problem/Medical Problem 1 1
Gastrointestinal Hemorrhage 1 1
Easy Bruising 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boddingtons Plastics Ltd II Apr-16-2020
2 Boston Scientific Corporation II Dec-04-2013
3 Olympus Corporation of the Americas II Sep-03-2021
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