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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device endoscopic access overtube, gastroenterology-urology
Regulation Description Endoscope and accessories.
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
CALYXO, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
H&A MUI ENTERPRISES INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KALERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 1
SEPLOU (ZHUHAI) 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
2020 33 33
2021 55 55
2022 36 36
2023 53 53
2024 63 63
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 38 38
Material Split, Cut or Torn 28 28
Adverse Event Without Identified Device or Use Problem 26 26
Material Integrity Problem 19 19
Break 16 16
Unsealed Device Packaging 14 14
Device Contamination with Chemical or Other Material 14 14
Flaked 9 9
Tear, Rip or Hole in Device Packaging 7 7
Detachment of Device or Device Component 7 7
Difficult to Advance 7 7
Device Contaminated During Manufacture or Shipping 6 6
Accessory Incompatible 6 6
Difficult to Insert 5 5
Material Deformation 5 5
Material Frayed 4 4
Material Twisted/Bent 4 4
Material Separation 4 4
Complete Blockage 4 4
Inflation Problem 4 4
Material Too Rigid or Stiff 4 4
Defective Device 3 3
Device-Device Incompatibility 3 3
Inability to Irrigate 3 3
Difficult to Remove 3 3
Insufficient Information 3 3
Partial Blockage 3 3
Unraveled Material 3 3
Material Protrusion/Extrusion 3 3
Material Fragmentation 3 3
Shipping Damage or Problem 2 2
Contamination 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 2 2
Packaging Problem 2 2
Disconnection 2 2
Crack 2 2
Restricted Flow rate 2 2
Device Contamination with Body Fluid 1 1
Nonstandard Device 1 1
Material Disintegration 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Use of Device Problem 1 1
Burst Container or Vessel 1 1
Device Damaged Prior to Use 1 1
Suction Failure 1 1
Unintended Deflation 1 1
Off-Label Use 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 164 164
No Consequences Or Impact To Patient 21 21
Insufficient Information 13 13
Perforation 8 8
Foreign Body In Patient 8 8
Hemorrhage/Bleeding 8 8
No Known Impact Or Consequence To Patient 6 6
Cardiac Arrest 5 5
No Information 4 4
No Patient Involvement 4 4
Respiratory Failure 4 4
Inflammation 4 4
Septic Shock 3 3
Hematuria 3 3
Unspecified Tissue Injury 3 3
Disseminated Intravascular Coagulation (DIC) 3 3
Unspecified Kidney or Urinary Problem 2 2
Increased Intra-Peritoneal Volume (IIPV) 2 2
Thrombosis/Thrombus 2 2
Vascular Dissection 2 2
Ascites 2 2
Perforation of Esophagus 2 2
Hypoxia 2 2
Fever 2 2
Aneurysm 2 2
Rupture 2 2
Shock 2 2
Pain 2 2
Necrosis 2 2
Laceration(s) 2 2
Ischemia 2 2
Low Blood Pressure/ Hypotension 1 1
Easy Bruising 1 1
Death 1 1
Erosion 1 1
Peritonitis 1 1
Discomfort 1 1
Injury 1 1
Laceration(s) of Esophagus 1 1
Air Embolism 1 1
Abdominal Pain 1 1
Chills 1 1
Blood Loss 1 1
Urinary Retention 1 1
Bowel Perforation 1 1
Tissue Damage 1 1
Pneumothorax 1 1
Gastrointestinal Hemorrhage 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
3 Trokamed GmbH I Jan-10-2025
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