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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
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BYRNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
C2 THERAPEUTICS, 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
CIPHER SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
DIVERSATEK HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ERBE USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 6
JETPREP, LTD.
  SUBSTANTIALLY EQUIVALENT 2
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOVATIONS, INC.
  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
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEPLA SAM
  SUBSTANTIALLY EQUIVALENT 1
SANESO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTDATA SUZHOU CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
THE RUHOF CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 3

MDR Year MDR Reports MDR Events
2014 5 5
2015 9 9
2016 8 8
2017 9 9
2018 18 18
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 100 100
Detachment of Device or Device Component 27 27
Material Fragmentation 14 14
Fluid/Blood Leak 9 9
Break 8 8
Device Operates Differently Than Expected 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Detachment Of Device Component 6 6
Positioning Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Defective Device 3 3
Device Issue 3 3
Gas/Air Leak 3 3
Entrapment of Device 3 3
Misassembled 2 2
Material Deformation 2 2
Device Handling Problem 2 2
Gas Output Problem 2 2
Suction Failure 2 2
Insufficient Information 2 2
Material Twisted/Bent 2 2
Naturally Worn 2 2
Optical Problem 1 1
Bent 1 1
Backflow 1 1
Difficult or Delayed Activation 1 1
Fitting Problem 1 1
Device Markings/Labelling Problem 1 1
Crack 1 1
Wrong Label 1 1
Device Fell 1 1
Collapse 1 1
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Use of Device Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Retraction Problem 1 1
Activation Failure 1 1
Contamination /Decontamination Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Incomplete or Inadequate Connection 1 1
Increase in Pressure 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Hole In Material 1 1
Device Operational Issue 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 55 55
No Known Impact Or Consequence To Patient 27 27
Foreign Body In Patient 6 6
Insufficient Information 5 5
No Information 4 4
Hemorrhage/Bleeding 4 4
No Code Available 2 2
Gastrointestinal Hemorrhage 1 1
Bowel Perforation 1 1
Aspiration/Inhalation 1 1
Hematoma 1 1
Perforation 1 1
Abdominal Distention 1 1
Abrasion 1 1
Keratitis 1 1
Obstruction/Occlusion 1 1
Fever 1 1
Irritation 1 1
Chills 1 1
Thrombosis/Thrombus 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Urinary Retention 1 1
Fall 1 1
Tissue Damage 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jan-26-2015
2 GA HEALTH COMPANY LIMITED II Dec-18-2020
3 Hobbs Medical, Inc. II Oct-07-2022
4 US Endoscopy Group Inc II Jul-01-2015
5 US Endoscopy Group Inc II Apr-11-2013
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