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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope channel accessory
Definition To give the endoscope channel additional or improved functionality.
Product CodeODC
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
ENDOSTART S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDWORK GMBH
  SUBSTANTIALLY EQUIVALENT 2
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 4
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS (A SUBSIDIARY OF STERIS CORPORATION)
  SUBSTANTIALLY EQUIVALENT 3
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMARTDATA SUZHOU CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SML MED-TECH SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  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 2
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 17 17
2019 40 40
2020 54 54
2021 52 52
2022 41 41
2023 67 67
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 153 153
Leak/Splash 57 57
Use of Device Problem 38 38
Break 23 23
Adverse Event Without Identified Device or Use Problem 20 20
Material Integrity Problem 17 17
Physical Resistance/Sticking 14 14
Device Dislodged or Dislocated 12 12
Fluid/Blood Leak 9 9
Material Split, Cut or Torn 9 9
Material Fragmentation 8 8
Entrapment of Device 7 7
Insufficient Information 7 7
Defective Device 6 6
Suction Problem 5 5
Difficult to Advance 5 5
Difficult to Open or Close 4 4
Crack 4 4
Device Reprocessing Problem 3 3
Material Separation 3 3
Difficult to Remove 3 3
Obstruction of Flow 3 3
Device Markings/Labelling Problem 2 2
Gas/Air Leak 2 2
Unsealed Device Packaging 2 2
Appropriate Term/Code Not Available 2 2
Packaging Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Optical Obstruction 1 1
Output Problem 1 1
Device Handling Problem 1 1
Device Fell 1 1
Product Quality Problem 1 1
Self-Activation or Keying 1 1
Problem with Sterilization 1 1
Improper or Incorrect Procedure or Method 1 1
Complete Blockage 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Structural Problem 1 1
Failure to Advance 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 166 166
No Consequences Or Impact To Patient 86 86
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 11 11
Foreign Body In Patient 6 6
No Patient Involvement 5 5
Urinary Tract Infection 2 2
Discomfort 1 1
Extubate 1 1
Abrasion 1 1
Airway Obstruction 1 1
Exposure to Body Fluids 1 1
Hematoma 1 1
Muscle Spasm(s) 1 1
Eye Infections 1 1
Unspecified Tissue Injury 1 1

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