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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
APOLLO ENDOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BYRNE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
BYRNE MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
EASYGLIDE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
N.M. BEALE CO. INC.
  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
SMART MEDICAL SYSTEMS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 3
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WILSON INSTRUMENTS (SHA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  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
2014 2 2
2015 3 3
2016 8 8
2017 12 12
2018 17 17
2019 40 40
2020 54 54
2021 52 52
2022 41 41
2023 67 67
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 164 164
Leak/Splash 59 59
Use of Device Problem 43 43
Break 25 25
Adverse Event Without Identified Device or Use Problem 20 20
Material Integrity Problem 17 17
Fluid/Blood Leak 16 16
Physical Resistance/Sticking 14 14
Device Dislodged or Dislocated 13 13
Material Split, Cut or Torn 9 9
Insufficient Information 9 9
Material Fragmentation 8 8
Entrapment of Device 7 7
Defective Device 6 6
Suction Problem 6 6
Material Separation 5 5
Difficult to Advance 5 5
Difficult to Open or Close 5 5
Obstruction of Flow 4 4
Difficult to Remove 4 4
Crack 4 4
Device Reprocessing Problem 3 3
Device Operates Differently Than Expected 3 3
Device Contamination with Chemical or Other Material 3 3
Improper or Incorrect Procedure or Method 2 2
Appropriate Term/Code Not Available 2 2
Detachment Of Device Component 2 2
Failure to Advance 2 2
Packaging Problem 2 2
Difficult or Delayed Positioning 2 2
Unsealed Device Packaging 2 2
Accessory Incompatible 2 2
Infusion or Flow Problem 2 2
Device Markings/Labelling Problem 2 2
Unintended Ejection 2 2
Gas/Air Leak 2 2
Connection Problem 1 1
Self-Activation or Keying 1 1
Optical Obstruction 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
Device Operational Issue 1 1
Device Handling Problem 1 1
Incomplete or Missing Packaging 1 1
Output Problem 1 1
Migration or Expulsion of Device 1 1
Disassembly 1 1
Defective Component 1 1
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 184 184
No Consequences Or Impact To Patient 88 88
No Known Impact Or Consequence To Patient 29 29
Insufficient Information 12 12
Foreign Body In Patient 8 8
No Patient Involvement 7 7
No Information 5 5
Exposure to Body Fluids 4 4
Urinary Tract Infection 2 2
No Code Available 1 1
Hematoma 1 1
Perforation 1 1
Abrasion 1 1
Muscle Spasm(s) 1 1
Discomfort 1 1
Eye Infections 1 1
Unspecified Tissue Injury 1 1
Extubate 1 1
Airway Obstruction 1 1

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