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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 5
Leak 4
Other (for use when an appropriate device code cannot be identified) 4
Failure to advance 4
Difficult to remove 3
Fitting problem 3
Peeled 2
Foreign material 2
Insulation, detached 1
Kinked 1
Normal 1
Fluid leak 1
Balloon rupture 1
Bent 1
Component(s), broken 1
Device, or device fragments remain in patient 1
Source, detachment from 1
Defective item 1
Device damaged prior to use 1
Wire(s), breakage of 1
Total Device Problems 39

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