TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	22	22
Fluid/Blood Leak	6	6
Difficult to Advance	6	6
Device Contamination with Chemical or Other Material	4	4
Packaging Problem	3	3
Break	3	3
Device Fell	3	3
Material Deformation	2	2
Insufficient Information	2	2
Patient Device Interaction Problem	2	2
Detachment of Device or Device Component	2	2
Unintended Movement	1	1
Physical Resistance/Sticking	1	1
Improper Flow or Infusion	1	1
Device Contaminated During Manufacture or Shipping	1	1
Loose or Intermittent Connection	1	1
Peeled/Delaminated	1	1
Improper or Incorrect Procedure or Method	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	18	18
Pancreatitis	14	14
Perforation	7	7
No Known Impact Or Consequence To Patient	4	4
No Consequences Or Impact To Patient	3	3
Insufficient Information	3	3
Injury	2	2
Device Embedded In Tissue or Plaque	2	2
No Code Available	2	2
Unspecified Hepatic or Biliary Problem	2	2
Hemorrhage/Bleeding	2	2
Hypoxia	2	2
Inflammation	1	1
Sepsis	1	1
Failure to Anastomose	1	1
Abdominal Pain	1	1
Abscess	1	1
Adult Respiratory Distress Syndrome	1	1
Exposure to Body Fluids	1	1
Conjunctivitis	1	1
Chemical Exposure	1	1
No Patient Involvement	1	1
Intraoperative Pain	1	1