TPLC - Total Product Life Cycle

• 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
APOLLO ENDOSURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BYRNE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
BYRNE MEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
EASYGLIDE LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCHOICE, 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
N.M. BEALE CO. INC.
	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
SMART MEDICAL SYSTEMS, LTD.
	SUBSTANTIALLY EQUIVALENT	3
SMARTDATA SUZHOU CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SML MED-TECH SOLUTIONS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
1.  K202104  BioGuard EUS Air/Water and Suction Valves
2.  K210342  BioShield- ERCP Biopsy Valve, BioShield Irrigator ...
3.  K240098  DEFENDO Single Use Valve Kit AW/S Valves - 2pc for ...
4.  K240352  Defendo Single Use Cleaning Adapter for Olympus En ...
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
1.  K202104  BioGuard EUS Air/Water and Suction Valves
2.  K210342  BioShield- ERCP Biopsy Valve, BioShield Irrigator ...
3.  K240098  DEFENDO Single Use Valve Kit AW/S Valves - 2pc for ...
4.  K240352  Defendo Single Use Cleaning Adapter for Olympus En ...
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	3
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILSON COOK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
WILSON INSTRUMENTS (SHA) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	3	3
2016	8	8
2017	12	12
2018	17	17
2019	40	40
2020	54	54
2021	52	52
2022	41	41
2023	67	67
2024	22	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	152	152
Leak/Splash	59	59
Use of Device Problem	39	39
Break	21	21
Adverse Event Without Identified Device or Use Problem	20	20
Material Integrity Problem	17	17
Fluid/Blood Leak	16	16
Physical Resistance/Sticking	14	14
Device Dislodged or Dislocated	13	13
Material Split, Cut or Torn	9	9
Insufficient Information	7	7
Entrapment of Device	7	7
Material Fragmentation	6	6
Defective Device	6	6
Difficult to Advance	5	5
Difficult to Open or Close	5	5
Suction Problem	5	5
Obstruction of Flow	4	4
Crack	4	4
Difficult to Remove	4	4
Material Separation	4	4
Device Reprocessing Problem	3	3
Device Operates Differently Than Expected	3	3
Device Contamination with Chemical or Other Material	3	3
Gas/Air Leak	2	2
Appropriate Term/Code Not Available	2	2
Packaging Problem	2	2
Device Markings/Labelling Problem	2	2
Detachment Of Device Component	2	2
Failure to Advance	2	2
Improper or Incorrect Procedure or Method	2	2
Unintended Ejection	2	2
Unsealed Device Packaging	2	2
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Problem with Sterilization	1	1
Self-Activation or Keying	1	1
Kinked	1	1
Complete Blockage	1	1
Disassembly	1	1
Defective Component	1	1
Incomplete or Missing Packaging	1	1
Structural Problem	1	1
Connection Problem	1	1
Device Operational Issue	1	1
Therapeutic or Diagnostic Output Failure	1	1
Optical Obstruction	1	1
Output Problem	1	1
Device Handling Problem	1	1
Device Fell	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Shut Off	1	1
Material Twisted/Bent	1	1
Mechanical Jam	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	88	88
No Known Impact Or Consequence To Patient	29	29
Insufficient Information	11	11
No Patient Involvement	7	7
Foreign Body In Patient	7	7
No Information	5	5
Exposure to Body Fluids	4	4
Urinary Tract Infection	2	2
No Code Available	1	1
Eye Infections	1	1
Unspecified Tissue Injury	1	1
Hematoma	1	1
Muscle Spasm(s)	1	1
Abrasion	1	1
Airway Obstruction	1	1
Discomfort	1	1
Extubate	1	1