TPLC - Total Product Life Cycle

• Device: endoscopic retrograde cholangiopancreatography (ercp) cannula
• Regulation Description: Endoscope and accessories.
• Definition: To identify stones, tumors, or narrowing in the biliary tree.
• Product Code: ODD
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	8	8
2022	11	11
2023	15	15
2024	12	12
2025	5	5
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	26	26
Difficult to Advance	7	7
Break	4	4
Packaging Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Device Fell	2	2
Patient Device Interaction Problem	2	2
Material Deformation	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Physical Resistance/Sticking	1	1
Poor Quality Image	1	1
Peeled/Delaminated	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20	20
Pancreatitis	17	17
Perforation	8	8
Insufficient Information	4	4
Hemorrhage/Bleeding	3	3
Inflammation	2	2
Unspecified Hepatic or Biliary Problem	2	2
Hypoxia	2	2
Device Embedded In Tissue or Plaque	2	2
Abdominal Pain	1	1
Unspecified Infection	1	1
Adult Respiratory Distress Syndrome	1	1
Sepsis	1	1
Gastrointestinal Hemorrhage	1	1
Bowel Perforation	1	1
Foreign Body In Patient	1	1
Failure to Anastomose	1	1
Abscess	1	1