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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dislodger, stone, basket, ureteral, metal
Regulation Description Ureteral stone dislodger.
Product CodeFFL
Regulation Number 876.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
VPI
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 182
Detachment of device component 99
Difficult to open or close 94
Material separation 62
Close, difficult to 55
Detachment of device or device component 43
Foreign material present in device 39
Device inoperable 36
Wire(s), breakage of 36
Device Issue 36
Material discolored 30
Component(s), broken 21
Difficult to remove 21
No Information 20
Tear, rip or hole in device packaging 19
Malfunction 19
Retraction problem 15
Failure to deploy 13
Device, or device fragments remain in patient 13
Device operates differently than expected 11
Defective item 10
Device damaged prior to use 10
Source, detachment from 10
Mechanical issue 9
Device, removal of (non-implant) 8
Foreign material 7
Other (for use when an appropriate device code cannot be identified) 7
Device packaging compromised 7
Defective component 6
Entrapment of device or device component 6
Unintended collision 5
Difficult to deploy 5
Component missing 5
Unknown (for use when the device problem is not known) 5
Tip breakage 5
Device or device fragments location unknown 4
Bent 4
Fracture 4
Kinked 4
Torn material 4
No Known Device Problem 4
Unsealed device packaging 3
Material fragmentation 3
Incomplete or missing packaging 3
Split 3
Failure to align 2
Sterility 2
Improper or incorrect procedure or method 2
Blank screen 2
Contamination during use 2
Mislabeled 2
Delivered as unsterile product 2
Packaging issue 2
No code available 1
Device abrasion from instrument or another object 1
Loose or intermittent connection 1
Device maintenance issue 1
Flaked 1
Peeled 1
User used incorrect product for intended use 1
Product quality issue 1
Shaft break 1
Slippage of device or device component 1
Cable break 1
Failure to capture 1
Material frayed 1
Handpiece break 1
Hole in material 1
Difficult to insert 1
Disassembly 1
Disconnection 1
Material disintegration 1
Material perforation 1
Sticking 1
Uncoiled 1
Out-of-box failure 1
Cut in material 1
Buckled material 1
Difficult to advance 1
Material deformation 1
Material twisted 1
Mechanical jam 1
Total Device Problems 1050

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Oct-31-2014
2 Sterilmed Inc II Jan-13-2009

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