Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device endoscope channel accessory
Regulation Description Endoscope and accessories.
Definition To give the endoscope channel additional or improved functionality.
Product CodeODC
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT - KIT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENDOSOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOSTART S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDWORK GMBH
  SUBSTANTIALLY EQUIVALENT 2
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS (A SUBSIDIARY OF STERIS CORPORATION)
  SUBSTANTIALLY EQUIVALENT 3
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SML MED-TECH SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPARATION
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WILSON INSTRUMENTS (SHA) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 52 52
2022 37 37
2023 43 43
2024 100 100
2025 91 91
2026 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 172 172
Leak/Splash 65 65
Use of Device Problem 36 36
Physical Resistance/Sticking 33 33
Fluid/Blood Leak 32 32
Adverse Event Without Identified Device or Use Problem 22 22
Difficult or Delayed Positioning 16 16
Material Integrity Problem 13 13
Device Slipped 12 12
Material Separation 11 11
Insufficient Information 10 10
Defective Device 10 10
Entrapment of Device 8 8
Infusion or Flow Problem 7 7
Break 6 6
Suction Problem 5 5
Unsealed Device Packaging 4 4
Microbial Contamination of Device 4 4
Difficult to Advance 4 4
Device Dislodged or Dislocated 4 4
Difficult to Open or Close 4 4
Material Fragmentation 3 3
Device-Device Incompatibility 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Insert 2 2
Device Markings/Labelling Problem 2 2
Accessory Incompatible 2 2
Packaging Problem 2 2
Output Problem 2 2
Failure to Advance 2 2
Appropriate Term/Code Not Available 2 2
Device Reprocessing Problem 2 2
Fitting Problem 2 2
Difficult to Remove 1 1
Device Difficult to Setup or Prepare 1 1
Problem with Sterilization 1 1
Crack 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 319 319
Insufficient Information 14 14
Foreign Body In Patient 6 6
No Consequences Or Impact To Patient 6 6
Perforation 3 3
Exposure to Body Fluids 2 2
Pancreatitis 1 1
Aspiration/Inhalation 1 1
Hematoma 1 1
Abrasion 1 1
Eye Infections 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Mar-20-2026
-
-