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
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
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMARTDATA SUZHOU CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SML MED-TECH SOLUTIONS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC.
	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
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	145	145
Leak/Splash	57	57
Use of Device Problem	36	36
Adverse Event Without Identified Device or Use Problem	20	20
Break	18	18
Material Integrity Problem	17	17
Physical Resistance/Sticking	14	14
Material Split, Cut or Torn	9	9
Insufficient Information	7	7
Device Dislodged or Dislocated	7	7
Entrapment of Device	7	7
Fluid/Blood Leak	7	7
Material Fragmentation	6	6
Defective Device	6	6
Suction Problem	5	5
Difficult to Advance	5	5
Difficult to Open or Close	4	4
Crack	4	4
Difficult to Remove	3	3
Material Separation	3	3
Device Reprocessing Problem	3	3
Unsealed Device Packaging	2	2
Obstruction of Flow	2	2
Device Markings/Labelling Problem	2	2
Gas/Air Leak	2	2
Appropriate Term/Code Not Available	2	2
Packaging Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	1
Mechanical Jam	1	1
Optical Obstruction	1	1
Output Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Shut Off	1	1
Device Contamination with Chemical or Other Material	1	1
Structural Problem	1	1
Failure to Advance	1	1
Connection Problem	1	1
Problem with Sterilization	1	1
Defective Component	1	1
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Complete Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160	160
No Consequences Or Impact To Patient	76	76
No Known Impact Or Consequence To Patient	13	13
Insufficient Information	11	11
Foreign Body In Patient	6	6
No Patient Involvement	4	4
Urinary Tract Infection	2	2
Discomfort	1	1
Extubate	1	1
Abrasion	1	1
Airway Obstruction	1	1
Hematoma	1	1
Muscle Spasm(s)	1	1
Eye Infections	1	1
Unspecified Tissue Injury	1	1