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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 147
No code available 86
Material deformation 73
Detachment of device component 69
Other (for use when an appropriate device code cannot be identified) 45
Torn material 37
Difficult to remove 31
Failure to separate 25
Tip breakage 21
Component(s), broken 19
Source, detachment from 18
Wire(s), breakage of 17
Device Issue 17
Device, or device fragments remain in patient 17
Leak 15
Handpiece break 10
Difficult to open or close 9
Fracture 8
Tears, rips, holes in device, device material 8
Mechanical issue 8
Device damaged prior to use 8
No Known Device Problem 7
Split 6
Device handling issue 6
Mechanical jam 5
Defective item 5
Use of Device Issue 5
Device inoperable 5
Detachment of device or device component 4
Failure to disconnect 4
Malfunction 3
Crack 3
Device expiration issue 3
Normal 3
Peeled 3
Retraction problem 3
Smoking 2
Unknown (for use when the device problem is not known) 2
Component missing 2
Shaft, split 2
Difficult to deploy 2
Fail-safe design failure 2
Unsealed device packaging 2
Entrapment of device or device component 2
Difficult to insert 2
Close, difficult to 2
Device markings issue 1
Failure to flush 1
Device or device fragments location unknown 1
Premature deployment 1
Slippage of device or device component 1
Material separation 1
Handpiece detachment 1
Accessory incompatible 1
Blockage within device or device component 1
Size incorrect for patient 1
Device, removal of (non-implant) 1
Incorrect device or component shipped 1
Material frayed 1
Twisting 1
Structural problem 1
Buckled material 1
Incorrect measurement 1
Improper or incorrect procedure or method 1
Tear, rip or hole in device packaging 1
Failure to advance 1
Application interface becomes non-functional or program exits abnormally 1
Physical resistance 1
Material twisted 1
Migration of device or device component 1
Total Device Problems 797

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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