TPLC - Total Product Life Cycle

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Device	choledochoscope and accessories, flexible/rigid
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	4
CENTERPOINT SYSTEMS LLC
	SUBSTANTIALLY EQUIVALENT	1
ENDOCURE TECHNOLOGIES, INC.
	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
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
Material Protrusion/Extrusion	1063	1063
Optical Problem	626	626
Appropriate Term/Code Not Available	320	320
Poor Quality Image	174	174
Device-Device Incompatibility	103	103
Adverse Event Without Identified Device or Use Problem	89	89
Difficult to Advance	44	44
Break	19	19
Insufficient Information	18	18
Peeled/Delaminated	16	16
Defective Device	15	15
Detachment Of Device Component	14	14
Connection Problem	12	12
Detachment of Device or Device Component	11	11
No Display/Image	7	7
Mechanical Problem	7	7
Material Integrity Problem	7	7
Microbial Contamination of Device	5	5
Positioning Problem	5	5
Contamination	4	4
Therapeutic or Diagnostic Output Failure	4	4
Difficult to Open or Close	3	3
Entrapment of Device	3	3
Unsealed Device Packaging	3	3
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Material Deformation	2	2
Failure to Power Up	2	2
Unexpected Shutdown	2	2
Material Split, Cut or Torn	2	2
Leak/Splash	2	2
Difficult to Remove	2	2
Collapse	1	1
Defective Component	1	1
Energy Output Problem	1	1
Torn Material	1	1
Device Alarm System	1	1
Image Display Error/Artifact	1	1
Communication or Transmission Problem	1	1
Material Fragmentation	1	1
Device Packaging Compromised	1	1
Use of Device Problem	1	1
Output Problem	1	1
Compatibility Problem	1	1
Fitting Problem	1	1
Material Perforation	1	1
Material Separation	1	1
Retraction Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Disinfection Or Sterilization Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1197	1197
No Clinical Signs, Symptoms or Conditions	569	569
No Known Impact Or Consequence To Patient	58	58
Injury	19	19
Inflammation	18	18
Perforation	16	16
Hemorrhage/Bleeding	15	15
Pancreatitis	8	8
Insufficient Information	8	8
No Patient Involvement	7	7
No Code Available	6	6
Unspecified Respiratory Problem	6	6
Laceration(s)	5	5
Unspecified Infection	4	4
Sepsis	4	4
Air Embolism	3	3
Cardiac Arrest	3	3
Fever	3	3
Pain	3	3
Fistula	3	3
Death	2	2
No Information	2	2
Unspecified Hepatic or Biliary Problem	2	2
Pneumonia	2	2
Patient Problem/Medical Problem	1	1
Liver Failure	1	1
Pneumothorax	1	1
Gastrointestinal Hemorrhage	1	1
Abrasion	1	1
Peritonitis	1	1
Foreign Body In Patient	1	1
Septic Shock	1	1
Dyspnea	1	1
Tissue Damage	1	1
Ascites	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Boston Scientific Corporation	II	Mar-19-2018
3	Olympus Corporation of the Americas	II	May-20-2022
4	Olympus Corporation of the Americas	II	Oct-16-2020
5	Olympus Corporation of the Americas	II	Feb-24-2017
6	Pentax Medical Company	II	Jun-28-2016