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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 152
Detachment of device component 96
Difficult to open or close 83
Close, difficult to 55
Material separation 51
Detachment of device or device component 36
Foreign material present in device 36
Device inoperable 36
Wire(s), breakage of 36
Device Issue 36
Material discolored 30
Component(s), broken 21
No Information 20
Malfunction 19
Difficult to remove 18
Tear, rip or hole in device packaging 17
Retraction problem 15
Failure to deploy 13
Device, or device fragments remain in patient 13
Device damaged prior to use 10
Source, detachment from 10
Defective item 10
Mechanical issue 9
Device, removal of (non-implant) 8
Foreign material 7
Device packaging compromised 7
Other (for use when an appropriate device code cannot be identified) 7
Defective component 6
Component missing 5
Unknown (for use when the device problem is not known) 5
Tip breakage 5
Difficult to deploy 5
Unintended collision 5
Entrapment of device or device component 4
Kinked 4
Bent 4
Fracture 4
No Known Device Problem 4
Device or device fragments location unknown 4
Split 3
Incomplete or missing packaging 3
Unsealed device packaging 3
Mislabeled 2
Delivered as unsterile product 2
Blank screen 2
Contamination during use 2
Sterility 2
Improper or incorrect procedure or method 2
Failure to align 2
Cut in material 1
Device operates differently than expected 1
Packaging issue 1
Difficult to advance 1
Material deformation 1
Mechanical jam 1
Material perforation 1
Sticking 1
Uncoiled 1
Out-of-box failure 1
Cable break 1
Failure to capture 1
Material fragmentation 1
Material frayed 1
Handpiece break 1
Hole in material 1
Difficult to insert 1
Disassembly 1
Disconnection 1
Material disintegration 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
No code available 1
Total Device Problems 959

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 1 0 0
Class III 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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