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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biopsy needle
Regulation Description Gastroenterology-urology biopsy instrument.
Product CodeFCG
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUSON
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
H.S. HOSPITAL SERVICES S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
HAAKO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Misfire 161
Break 118
Retraction problem 96
Loose 89
Bent 52
Unknown (for use when the device problem is not known) 35
No Known Device Problem 34
Occlusion within device 25
Other (for use when an appropriate device code cannot be identified) 22
Difficult to remove 20
Unstable 19
Difficult to advance 19
Material puncture 14
Detachment of device component 14
Kinked 11
Material separation 11
Tip breakage 10
Failure to obtain samples 8
Failure to fire 7
Detachment of device or device component 7
Needle, separation 7
No code available 6
Failure to advance 6
Device Issue 5
Device markings issue 5
Locking mechanism failure 4
Failure to deploy 4
Blockage within device or device component 3
Component(s), broken 3
Fracture 3
Needle, unsheathed 3
Sticking 3
Use of Device Issue 2
Material fragmentation 2
Difficult to deploy 2
Physical resistance 2
Malfunction 2
Fitting problem 2
Device-device incompatibility 2
No Information 2
Foreign material present in device 2
Device handling issue 2
Material integrity issue 1
Mechanical jam 1
Obstruction within device 1
Material perforation 1
Device damaged prior to use 1
Seal, defective 1
Device or device fragments location unknown 1
Catheter withdrawal interference 1
Dislodged 1
Fluid leak 1
Material frayed 1
Handpiece break 1
Insulation, detached 1
Leak 1
Mechanical issue 1
Improper or incorrect procedure or method 1
Device inoperable 1
Unraveled material 1
Product quality issue 1
Device, or device fragments remain in patient 1
Normal 1
Unsealed device packaging 1
Device Difficult to Setup or Prepare 1
Slippage of device or device component 1
Sterility 1
Total Device Problems 869

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 2 1 1 0 0 0 0 1
Class III 0 1 1 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Aug-16-2016
2 Bard Peripheral Vascular Inc II Nov-17-2009
3 Boston Scientific Corp III Jan-12-2009
4 Boston Scientific Corporation III Sep-16-2011
5 Boston Scientific Corporation II Dec-27-2010
6 Boston Scientific Corporation III Nov-28-2008
7 Cardinal Health II Nov-09-2009
8 Olympus America Inc. II Oct-07-2011

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