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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic irrigation/suction system
Definition To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Product CodeOCX
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTEX INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING JINSHAN SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIPHER SURGICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DIVERSATEK HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ERBE USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 6
HOBBS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS
  SUBSTANTIALLY EQUIVALENT 1
NISSHA MEDICAL TECHNOLOGIES SAS
  SUBSTANTIALLY EQUIVALENT 1
PARTNERSHIP MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
PENTAX MEDICAL, A DIVISION OF PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANESO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTDATA SUZHOU CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 41 41
2020 11 11
2021 8 8
2022 18 18
2023 52 52
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 94 94
Detachment of Device or Device Component 24 24
Material Fragmentation 7 7
Break 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Positioning Problem 4 4
Fluid/Blood Leak 4 4
Entrapment of Device 3 3
Defective Device 3 3
Gas/Air Leak 3 3
Suction Failure 2 2
Material Twisted/Bent 2 2
Device Handling Problem 2 2
Gas Output Problem 2 2
Incomplete or Inadequate Connection 1 1
Device Markings/Labelling Problem 1 1
Collapse 1 1
Insufficient Information 1 1
Device Fell 1 1
Wrong Label 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination /Decontamination Problem 1 1
Backflow 1 1
Use of Device Problem 1 1
Difficult or Delayed Activation 1 1
Misassembled 1 1
Optical Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Activation Failure 1 1
Increase in Pressure 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 82 82
No Consequences Or Impact To Patient 31 31
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 5 5
Foreign Body In Patient 3 3
Hemorrhage/Bleeding 2 2
No Code Available 1 1
Gastrointestinal Hemorrhage 1 1
Hematoma 1 1
Abdominal Distention 1 1
Abrasion 1 1
Keratitis 1 1
Obstruction/Occlusion 1 1
Thrombosis/Thrombus 1 1
Urinary Retention 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GA HEALTH COMPANY LIMITED II Dec-18-2020
2 Hobbs Medical, Inc. II Oct-07-2022
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