TPLC - Total Product Life Cycle

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Device	choledochoscope and accessories, flexible/rigid
Regulation Description	Endoscope and accessories.
Definition	to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	FBN
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CENTERPOINT SYSTEMS LLC
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Optical Problem	622	622
Appropriate Term/Code Not Available	314	314
Poor Quality Image	168	168
Device-Device Incompatibility	100	100
Adverse Event Without Identified Device or Use Problem	88	88
Difficult to Advance	32	32
Peeled/Delaminated	17	17
Break	14	14
Connection Problem	12	12
Defective Device	11	11
Device Reprocessing Problem	9	9
Mechanical Problem	7	7
Material Integrity Problem	6	6
Detachment of Device or Device Component	5	5
Positioning Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Difficult to Open or Close	3	3
Material Split, Cut or Torn	2	2
Unexpected Shutdown	2	2
No Display/Image	2	2
Unsealed Device Packaging	2	2
Contamination	2	2
Failure to Power Up	2	2
Material Deformation	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Fitting Problem	1	1
Compatibility Problem	1	1
Entrapment of Device	1	1
Communication or Transmission Problem	1	1
Output Problem	1	1
Device Alarm System	1	1
Image Display Error/Artifact	1	1
Energy Output Problem	1	1
Microbial Contamination of Device	1	1
Scratched Material	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Contamination with Chemical or Other Material	1	1
Fluid/Blood Leak	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	621	621
No Consequences Or Impact To Patient	172	172
Perforation	11	11
Pancreatitis	9	9
Insufficient Information	8	8
Inflammation	6	6
Unspecified Respiratory Problem	6	6
No Code Available	5	5
Hemorrhage/Bleeding	5	5
Sepsis	4	4
Cardiac Arrest	3	3
No Known Impact Or Consequence To Patient	3	3
Fever	3	3
Pain	3	3
Fistula	3	3
Air Embolism	2	2
Unspecified Hepatic or Biliary Problem	2	2
Pneumonia	2	2
Unspecified Infection	1	1
Liver Failure	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
Pneumothorax	1	1
Gastrointestinal Hemorrhage	1	1
Peritonitis	1	1
Septic Shock	1	1
Discomfort	1	1
Dyspnea	1	1
Bacterial Infection	1	1
Ascites	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Olympus Corporation of the Americas	I	Jan-16-2025
3	Olympus Corporation of the Americas	II	May-20-2022
4	Olympus Corporation of the Americas	II	Oct-16-2020