TPLC - Total Product Life Cycle

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Device	endoscope channel accessory
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 CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
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 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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	180	180
Leak/Splash	62	62
Use of Device Problem	42	42
Physical Resistance/Sticking	31	31
Adverse Event Without Identified Device or Use Problem	21	21
Break	18	18
Material Integrity Problem	16	16
Material Split, Cut or Torn	9	9
Insufficient Information	9	9
Difficult or Delayed Positioning	9	9
Material Fragmentation	8	8
Fluid/Blood Leak	7	7
Entrapment of Device	7	7
Material Separation	7	7
Defective Device	6	6
Device Dislodged or Dislocated	6	6
Device Slipped	5	5
Difficult to Advance	5	5
Suction Problem	5	5
Crack	4	4
Difficult to Open or Close	4	4
Infusion or Flow Problem	4	4
Device Reprocessing Problem	3	3
Accessory Incompatible	2	2
Device Markings/Labelling Problem	2	2
Unsealed Device Packaging	2	2
Difficult to Remove	2	2
Appropriate Term/Code Not Available	2	2
Packaging Problem	2	2
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Optical Obstruction	1	1
Connection Problem	1	1
Failure to Advance	1	1
Device Contamination with Chemical or Other Material	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
Output Problem	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	242	242
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	5
Perforation	3	3
No Patient Involvement	3	3
Exposure to Body Fluids	2	2
Urinary Tract Infection	2	2
Pancreatitis	1	1
Hematoma	1	1
Aspiration/Inhalation	1	1
Abrasion	1	1
Discomfort	1	1
Eye Infections	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1