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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biopsy needle kit
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 4
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 3
HAAKO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Misfire 161
Loose 89
Unknown (for use when the device problem is not known) 35
Retraction problem 25
Occlusion within device 22
Other (for use when an appropriate device code cannot be identified) 22
Bent 19
Unstable 19
Material puncture 7
Break 7
Detachment of device component 6
Difficult to remove 6
Material separation 6
No code available 6
Device Issue 4
Locking mechanism failure 4
Failure to advance 4
Difficult to advance 4
Failure to deploy 4
Blockage within device or device component 3
Failure to fire 3
Kinked 3
Failure to obtain samples 3
Physical resistance 2
Detachment of device or device component 2
No Information 2
Component(s), broken 2
Difficult to deploy 2
Fracture 2
Needle, separation 2
Needle, unsheathed 1
Normal 1
Insulation, detached 1
Unsealed device packaging 1
Device Difficult to Setup or Prepare 1
Dislodged 1
Fluid leak 1
Slippage of device or device component 1
Sterility 1
Sticking 1
Tip breakage 1
Device inoperable 1
Unraveled material 1
Use of Device Issue 1
Material perforation 1
Device damaged prior to use 1
Seal, defective 1
Device handling issue 1
Catheter withdrawal interference 1
Foreign material present in device 1
Material integrity issue 1
No Known Device Problem 1
Device or device fragments location unknown 1
Malfunction 1
Obstruction within device 1
Total Device Problems 501

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 2 1 1 0 0
Class III 0 1 1 0 1 0 0

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

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