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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dislodger, stone, biliary
Regulation Description Biliary catheter and accessories.
Product CodeLQR
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 48
Failure to conduct 13
Component(s), broken 10
Bent 8
Failure to cut 8
No code available 8
Wire(s), breakage of 7
Material rupture 7
Electrical issue 6
Other (for use when an appropriate device code cannot be identified) 5
Kinked 4
Melted 4
Normal 4
Failure to deliver energy 4
Failure to align 3
Split 3
Torn material 3
Electrical power problem 2
No Known Device Problem 2
Extrusion 1
Foreign material present in device 1
Not Applicable 1
Buckled material 1
Entrapment of device or device component 1
Deflation issue 1
Disengaged 1
Detachment of device component 1
Burst 1
Device Cleaning Issue 1
Material separation 1
Use of Device Issue 1
Device Issue 1
Total Device Problems 162

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corp II Mar-11-2009

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