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
CENTERPOINT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRCO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TANGENT ENDOSCOPY, LLC
	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	548	548
Appropriate Term/Code Not Available	156	156
Poor Quality Image	154	155
Adverse Event Without Identified Device or Use Problem	98	98
Device-Device Incompatibility	94	94
Difficult to Advance	27	27
Peeled/Delaminated	19	19
Break	15	15
Corroded	14	14
Device Reprocessing Problem	12	12
Detachment of Device or Device Component	11	11
Failure to Clean Adequately	9	9
No Display/Image	8	8
Mechanical Problem	8	8
Connection Problem	8	8
Defective Device	8	8
Material Integrity Problem	7	7
Mechanical Jam	6	6
Material Deformation	5	5
Fitting Problem	4	4
Material Split, Cut or Torn	4	4
Physical Resistance/Sticking	4	4
Crack	4	4
Contamination	4	4
Gas/Air Leak	4	4
Difficult to Open or Close	3	3
Residue After Decontamination	3	3
Positioning Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Scratched Material	3	3
Material Discolored	3	3
Positioning Failure	3	3
Difficult to Insert	3	3
Improper or Incorrect Procedure or Method	2	2
Loose or Intermittent Connection	2	2
Display or Visual Feedback Problem	2	2
Erratic or Intermittent Display	2	2
Material Fragmentation	2	2
Degraded	2	2
Microbial Contamination of Device	2	2
Unsealed Device Packaging	2	2
Display Difficult to Read	2	2
Output Problem	2	3
Unstable	2	2
Key or Button Unresponsive/not Working	1	1
Dent in Material	1	1
Contamination /Decontamination Problem	1	1
Thermal Decomposition of Device	1	1
Material Perforation	1	1
Energy Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	774	775
Perforation	11	11
No Consequences Or Impact To Patient	11	11
Pancreatitis	10	10
Insufficient Information	9	10
Unspecified Respiratory Problem	6	6
Hemorrhage/Bleeding	6	6
Sepsis	5	5
Inflammation	5	5
Cardiac Arrest	4	4
Fever	3	3
Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Hepatic or Biliary Problem	2	2
Pneumonia	2	2
Bacterial Infection	2	2
Air Embolism	1	1
Liver Failure	1	1
Pneumothorax	1	1
No Code Available	1	1
Gastrointestinal Hemorrhage	1	1
Peritonitis	1	1
Confusion/ Disorientation	1	1
Septic Shock	1	1
Discomfort	1	1
Dyspnea	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Ascites	1	1
Respiratory Failure	1	1
Fistula	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