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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stylet for catheter, gastro-urology
Regulation Description Urological catheter and accessories.
Product CodeEZB
Regulation Number 876.5130
Device Class 1


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 261
Peeled 234
Device damaged prior to use 58
Break 56
Tip breakage 53
Device, or device fragments remain in patient 49
Flaked 39
Other (for use when an appropriate device code cannot be identified) 31
Failure to advance 22
Difficult to remove 22
Source, detachment from 22
Material frayed 21
Tears, rips, holes in device, device material 21
Wire(s), breakage of 21
No Known Device Problem 19
Difficult to insert 17
Detachment of device or device component 15
Unraveled material 13
Physical resistance 12
Device or device component damaged by another device 11
Unknown (for use when the device problem is not known) 11
Kinked 11
Fracture 8
Loose 8
Split 7
Material separation 6
Stretched 5
Sharp/jagged/rough/etched/scratched 5
Material integrity issue 5
Difficult to advance 4
Defective item 4
Device Issue 4
Material fragmentation 4
Component(s), broken 3
Bent 3
Difficult to position 3
Fitting problem 3
Device, removal of (non-implant) 3
Incorrect device or component shipped 3
No code available 3
Foreign material present in device 2
Material deformation 2
Device packaging compromised 2
Device or device fragments location unknown 2
Uncoiled 2
Device inoperable 2
Component missing 2
Mislabeled 2
Normal 2
Retraction problem 2
Device expiration issue 2
Foreign material 2
Knotted 1
Interference 1
Abnormal 1
Crack 1
Dislodged 1
Blockage within device or device component 1
Pierce 1
Unsealed device packaging 1
Misplacement 1
Shaft, split 1
Size incorrect for patient 1
Specificity 1
Sterility 1
Sticking 1
Incomplete or missing packaging 1
Tube(s), buckling of 1
Tear, rip or hole in device packaging 1
Dull 1
Tracking 1
Wrinkled 1
Material Protrusion 1
Item contaminated during manufacturing or shipping 1
Positioning Issue 1
Torn material 1
No Information 1
Total Device Problems 1149

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

Recalls
Manufacturer Recall Class Date Posted
1 Cook Urological, Inc. II Aug-09-2007

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