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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 134
Retraction problem 101
Loose 89
Bent 55
Unknown (for use when the device problem is not known) 35
No Known Device Problem 35
Occlusion within device 27
Other (for use when an appropriate device code cannot be identified) 22
Difficult to remove 20
Unstable 19
Difficult to advance 19
Tear, rip or hole in device packaging 17
Detachment of device component 17
Material puncture 14
Material separation 12
Kinked 11
Tip breakage 10
Failure to obtain samples 8
Detachment of device or device component 8
Failure to fire 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
Device-device incompatibility 3
Device handling issue 2
No Information 2
Foreign material present in device 2
Malfunction 2
Physical resistance 2
Device or device fragments location unknown 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Fitting problem 2
Material fragmentation 2
Difficult to deploy 2
Dislodged 1
Fluid leak 1
Material frayed 1
Handpiece break 1
Insulation, detached 1
Leak 1
Mechanical issue 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
Obstruction within device 1
Device inoperable 1
Unraveled material 1
Material perforation 1
Device damaged prior to use 1
Defective component 1
Seal, defective 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanical jam 1
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Catheter withdrawal interference 1
Total Device Problems 925

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 2
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 Cook Inc. II Aug-22-2016
9 Olympus America Inc. II Oct-07-2011

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