TPLC - Total Product Life Cycle

• Device: endoscopic cytology brush
• Regulation Description: Endoscope and accessories.
• Definition: To collect cells for cytological evaluation.
• Product Code: FDX
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	19	19
2022	17	17
2023	17	18
2024	20	22
2025	11	11
2026	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	47	47
Adverse Event Without Identified Device or Use Problem	27	29
Break	12	12
Mechanical Problem	6	6
Material Deformation	5	5
Device Contaminated During Manufacture or Shipping	3	3
Material Fragmentation	3	3
Material Twisted/Bent	3	3
Retraction Problem	3	3
Unsealed Device Packaging	1	1
Contamination	1	1
Use of Device Problem	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Appropriate Device Problem Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	52
Foreign Body In Patient	23	23
Hemorrhage/Blood Loss/Bleeding	8	8
Pneumothorax	6	8
Pancreatitis	6	6
Bronchial Hemorrhage	3	3
Insufficient Information	3	3
Hemoptysis	2	2
Inflammation	2	2
Cholangitis	2	2
Abdominal Pain	1	1
Unspecified Infection	1	1
Perforation	1	1
Cardiac Arrest	1	1
Pain	1	1
Hypoxia	1	1
No Consequences Or Impact To Patient	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hobbs Medical, Inc.	II	Oct-07-2022
2	Hobbs Medical, Inc.	II	Mar-02-2022