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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
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
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 147 147
Leak/Splash 57 57
Use of Device Problem 36 36
Break 22 22
Adverse Event Without Identified Device or Use Problem 20 20
Material Integrity Problem 17 17
Physical Resistance/Sticking 14 14
Material Split, Cut or Torn 9 9
Material Fragmentation 8 8
Entrapment of Device 7 7
Fluid/Blood Leak 7 7
Device Dislodged or Dislocated 7 7
Insufficient Information 7 7
Defective Device 6 6
Difficult to Advance 5 5
Suction Problem 5 5
Crack 4 4
Difficult to Open or Close 4 4
Device Reprocessing Problem 3 3
Difficult to Remove 3 3
Material Separation 3 3
Unsealed Device Packaging 2 2
Obstruction of Flow 2 2
Device Markings/Labelling Problem 2 2
Gas/Air Leak 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 1 1
Optical Obstruction 1 1
Output Problem 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
Connection Problem 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Structural Problem 1 1
Failure to Advance 1 1
Defective Component 1 1
Product Quality Problem 1 1
Problem with Sterilization 1 1
Complete Blockage 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 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 76 76
No Known Impact Or Consequence To Patient 13 13
Insufficient Information 11 11
Foreign Body In Patient 6 6
No Patient Involvement 4 4
Urinary Tract Infection 2 2
Discomfort 1 1
Extubate 1 1
Abrasion 1 1
Airway Obstruction 1 1
Hematoma 1 1
Muscle Spasm(s) 1 1
Eye Infections 1 1
Unspecified Tissue Injury 1 1

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