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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 164
Detachment of device component 99
Difficult to open or close 85
Material separation 57
Close, difficult to 55
Detachment of device or device component 42
Foreign material present in device 38
Device Issue 36
Wire(s), breakage of 36
Device inoperable 36
Material discolored 30
Component(s), broken 21
No Information 20
Malfunction 19
Tear, rip or hole in device packaging 19
Difficult to remove 19
Retraction problem 15
Device, or device fragments remain in patient 13
Failure to deploy 13
Device damaged prior to use 10
Source, detachment from 10
Defective item 10
Mechanical issue 9
Device, removal of (non-implant) 8
Device packaging compromised 7
Other (for use when an appropriate device code cannot be identified) 7
Foreign material 7
Defective component 6
Tip breakage 5
Component missing 5
Unknown (for use when the device problem is not known) 5
Difficult to deploy 5
Unintended collision 5
Device or device fragments location unknown 4
Kinked 4
Entrapment of device or device component 4
No Known Device Problem 4
Bent 4
Fracture 4
Split 3
Torn material 3
Incomplete or missing packaging 3
Material fragmentation 3
Unsealed device packaging 3
Failure to align 2
Packaging issue 2
Sterility 2
Device operates differently than expected 2
Improper or incorrect procedure or method 2
Blank screen 2
Contamination during use 2
Delivered as unsterile product 2
Mislabeled 2
No code available 1
Disassembly 1
Device abrasion from instrument or another object 1
Material frayed 1
Failure to capture 1
Handpiece break 1
Product quality issue 1
Uncoiled 1
Material disintegration 1
Cut in material 1
Slippage of device or device component 1
Material perforation 1
Difficult to insert 1
Disconnection 1
Difficult to advance 1
Flaked 1
Loose or intermittent connection 1
Out-of-box failure 1
Mechanical jam 1
Hole in material 1
User used incorrect product for intended use 1
Cable break 1
Shaft break 1
Material deformation 1
Sticking 1
Device maintenance issue 1
Peeled 1
Total Device Problems 1000

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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