TPLC - Total Product Life Cycle

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Device	endoscopic irrigation/suction system
Regulation Description	Endoscope and accessories.
Definition	To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Product Code	OCX
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
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
1. K221824 OpClear Platform (CU3 DI3), OpClear Control Unit w ...
DIVERSATEK HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
ERBE USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SANESO, INC.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	70	70
Material Fragmentation	7	7
Detachment of Device or Device Component	6	6
Fluid/Blood Leak	5	5
Positioning Problem	4	4
Break	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device-Device Incompatibility	2	2
Defective Device	2	2
Device Handling Problem	2	2
Increase in Pressure	2	2
Suction Failure	2	2
Gas Output Problem	2	2
Material Twisted/Bent	2	2
Free or Unrestricted Flow	1	1
Wrong Label	1	1
Use of Device Problem	1	1
Corroded	1	1
Difficult or Delayed Activation	1	1
Incomplete or Inadequate Connection	1	1
Collapse	1	1
Optical Problem	1	1
Activation Failure	1	1
Nonstandard Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Insufficient Information	1	1
Contamination /Decontamination Problem	1	1
Backflow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	91	91
No Consequences Or Impact To Patient	6	6
Insufficient Information	5	5
No Known Impact Or Consequence To Patient	3	3
Foreign Body In Patient	2	2
Hemorrhage/Bleeding	2	2
Keratitis	1	1
Thrombosis/Thrombus	1	1
Bruise/Contusion	1	1
Hematoma	1	1
Gastrointestinal Hemorrhage	1	1
Obstruction/Occlusion	1	1