TPLC - Total Product Life Cycle

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Device	endoscope channel accessory
Regulation Description	Endoscope and accessories.
Definition	To give the endoscope channel additional or improved functionality.
Product Code	ODC
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
ANREI MEDICAL (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT - KIT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ENDOSOUND, 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
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SML MED-TECH SOLUTIONS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPARATION
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILSON COOK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
WILSON INSTRUMENTS (SHA) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO,. LTD
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	191	191
Leak/Splash	73	73
Use of Device Problem	46	46
Physical Resistance/Sticking	34	35
Fluid/Blood Leak	25	25
Adverse Event Without Identified Device or Use Problem	22	22
Material Integrity Problem	19	19
Defective Device	14	14
Difficult or Delayed Positioning	14	14
Device Slipped	11	11
Insufficient Information	10	10
Material Separation	9	9
Entrapment of Device	8	8
Suction Problem	8	9
Break	7	7
Difficult to Advance	7	7
Material Fragmentation	7	7
Infusion or Flow Problem	7	7
Device Dislodged or Dislocated	6	6
Unsealed Device Packaging	4	4
Difficult to Open or Close	4	4
Device-Device Incompatibility	3	3
Output Problem	3	3
Fitting Problem	2	2
Accessory Incompatible	2	2
Device Markings/Labelling Problem	2	2
Difficult to Remove	2	2
Appropriate Term/Code Not Available	2	2
Failure to Advance	2	2
Packaging Problem	2	2
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Optical Obstruction	1	1
Connection Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Inadequacy of Device Shape and/or Size	1	1
Problem with Sterilization	1	1
Gas/Air Leak	1	1
Obstruction of Flow	1	1
Device Difficult to Setup or Prepare	1	1
Difficult to Insert	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Component	1	1
Complete Blockage	1	1
Crack	1	1
Failure to Shut Off	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	284	284
No Consequences Or Impact To Patient	48	48
Insufficient Information	14	14
Foreign Body In Patient	6	6
No Known Impact Or Consequence To Patient	5	6
Perforation	3	3
No Patient Involvement	3	3
Exposure to Body Fluids	2	2
Pancreatitis	1	1
Aspiration/Inhalation	1	1
Hematoma	1	1
Abrasion	1	1
Discomfort	1	1
Eye Infections	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1