TPLC - Total Product Life Cycle

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Device	catheter, cholangiography
Regulation Description	Introduction/drainage catheter and accessories.
Product Code	GBZ
Regulation Number	878.4200
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3	3
Obstruction of Flow	3	3
Fitting Problem	2	2
Component or Accessory Incompatibility	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Split, Cut or Torn	2	2
Burst Container or Vessel	2	2
Entrapment of Device	2	2
Insufficient Information	2	2
Defective Device	2	2
Difficult to Insert	2	2
Component Missing	2	2
Detachment of Device or Device Component	2	2
Flushing Problem	2	2
Disconnection	1	1
No Display/Image	1	1
Unsealed Device Packaging	1	1
Positioning Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inadequate Instructions for Healthcare Professional	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Sharp Edges	1	1
Delivered as Unsterile Product	1	1
Material Deformation	1	1
Misassembly by Users	1	1
Product Quality Problem	1	1
Material Separation	1	1
Erratic or Intermittent Display	1	1
Fracture	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14	14
No Known Impact Or Consequence To Patient	7	7
Insufficient Information	6	6
Pneumothorax	4	4
No Information	2	2
Foreign Body In Patient	2	2
Pancreatitis	1	1
Perforation	1	1
No Consequences Or Impact To Patient	1	1