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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
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 1
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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 94 94
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
Entrapment of Device 3 3
Device Contamination with Chemical or Other Material 3 3
Gas/Air Leak 3 3
Device Issue 3 3
Defective Device 3 3
Gas Output Problem 2 2
Material Deformation 2 2
Material Twisted/Bent 2 2
Naturally Worn 2 2
Misassembled 2 2
Device Handling Problem 2 2
Insufficient Information 2 2
Suction Failure 2 2
Wrong Label 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Therapeutic or Diagnostic Output Failure 1 1
Optical Problem 1 1
Nonstandard Device 1 1
Increase in Pressure 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Crack 1 1
Collapse 1 1
Bent 1 1
Backflow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Operational Issue 1 1
Device Markings/Labelling Problem 1 1
Hole In Material 1 1
Difficult or Delayed Activation 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
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
Thrombosis/Thrombus 1 1
Gastrointestinal Hemorrhage 1 1
Irritation 1 1
Keratitis 1 1
Perforation 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Chills 1 1
Obstruction/Occlusion 1 1
Abdominal Distention 1 1
Bowel Perforation 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Erythema 1 1
Fall 1 1
Fever 1 1
Hematoma 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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