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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lithotriptor, biliary mechanical
Regulation Description Mechanical lithotriptor.
Product CodeLQC
Regulation Number 876.4500
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 179
Material deformation 101
No code available 86
Detachment of device component 70
Other (for use when an appropriate device code cannot be identified) 45
Difficult to remove 39
Torn material 37
Failure to separate 33
Tip breakage 21
Component(s), broken 19
Source, detachment from 18
Device, or device fragments remain in patient 17
Wire(s), breakage of 17
Device Issue 17
Device handling issue 16
Leak 15
Handpiece break 10
Difficult to open or close 9
Device damaged prior to use 8
Fracture 8
Mechanical issue 8
Tears, rips, holes in device, device material 8
No Known Device Problem 7
Detachment of device or device component 6
Split 6
Defective item 5
Device inoperable 5
Use of Device Issue 5
Mechanical jam 5
Failure to disconnect 4
Malfunction 3
Retraction problem 3
Normal 3
Peeled 3
Device expiration issue 3
Crack 3
Difficult to deploy 2
Entrapment of device or device component 2
Fail-safe design failure 2
Difficult to insert 2
Unsealed device packaging 2
Shaft, split 2
Unknown (for use when the device problem is not known) 2
Component missing 2
Smoking 2
Close, difficult to 2
Buckled material 1
Device markings issue 1
Incorrect device or component shipped 1
Material twisted 1
Tear, rip or hole in device packaging 1
Improper or incorrect procedure or method 1
Structural problem 1
Failure to advance 1
Device or device fragments location unknown 1
Device, removal of (non-implant) 1
Physical resistance 1
Size incorrect for patient 1
Slippage of device or device component 1
Material separation 1
Twisting 1
Migration of device or device component 1
Premature deployment 1
Failure to flush 1
Material frayed 1
Handpiece detachment 1
Incorrect measurement 1
Application interface becomes non-functional or program exits abnormally 1
Accessory incompatible 1
Blockage within device or device component 1
Total Device Problems 886

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 0 0 0 0 0 0 0 0
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Olympus America Inc. III Oct-31-2007

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