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
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT - KIT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DYNE MEDICAL GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOSOUND, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOSTART S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM MEDWORK GMBH
	SUBSTANTIALLY EQUIVALENT	2
GA HEALTH COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	176	176
Physical Resistance/Sticking	140	140
Fluid/Blood Leak	89	89
Leak/Splash	65	65
Suction Problem	53	53
Infusion or Flow Problem	51	51
Use of Device Problem	37	37
Adverse Event Without Identified Device or Use Problem	23	23
Difficult or Delayed Positioning	16	16
Material Integrity Problem	14	14
Device Slipped	12	12
Material Separation	12	12
Break	11	11
Difficult to Remove	11	11
Insufficient Device Problem Information	10	10
Difficult to Insert	8	8
Defective Device	7	7
Microbial Contamination of Device	6	6
Difficult to Advance	4	4
Unsealed Device Packaging	4	4
Material Fragmentation	4	4
Difficult to Open or Close	4	4
Entrapment of Device	3	3
Device Reprocessing Problem	3	3
Output Problem	2	2
Accessory Incompatible	2	2
Device Markings/Labelling Problem	2	2
Excess Flow or Over-Infusion	2	2
Packaging Problem	2	2
Human-Device Interface Problem	2	2
Device Contaminated During Manufacture or Shipping	1	1
Peeled/Delaminated	1	1
Device Difficult to Setup or Prepare	1	1
Device Contamination with Chemical or Other Material	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	493	493
Insufficient Information	14	14
Foreign Body In Patient	7	7
No Consequences Or Impact To Patient	6	6
Perforation	3	3
Exposure to Body Fluids	3	3
Unspecified Tissue Injury	2	2
Pancreatitis	1	1
Aspiration/Inhalation	1	1
Hematoma	1	1
Cholangitis	1	1
Abrasion	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Laceration(s)	1	1
Eye Infections	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jun-11-2026
2	Olympus Corporation of the Americas	II	Mar-20-2026