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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
Break 166
Misfire 161
Retraction problem 106
Loose 89
Bent 60
No Known Device Problem 37
Unknown (for use when the device problem is not known) 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 15
Material separation 13
Kinked 11
Tip breakage 10
Failure to obtain samples 8
Detachment of device or device component 8
Failure to fire 7
Needle, separation 7
Failure to advance 6
No code available 6
Device markings issue 5
Device Issue 5
Locking mechanism failure 4
Fracture 4
Failure to deploy 4
Blockage within device or device component 3
Component(s), broken 3
Material fragmentation 3
Needle, unsheathed 3
Sticking 3
Device-device incompatibility 3
Difficult to deploy 2
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
Defective component 2
Seal, defective 1
Material perforation 1
Device damaged prior to use 1
Obstruction within device 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanical jam 1
Catheter withdrawal interference 1
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Dislodged 1
Fluid leak 1
Material frayed 1
Handpiece break 1
Insulation, detached 1
Leak 1
Mechanical issue 1
Device inoperable 1
Unraveled material 1
Slippage of device or device component 1
Sterility 1
Normal 1
Unsealed device packaging 1
Device Difficult to Setup or Prepare 1
Product quality issue 1
Failure to transmit record 1
Device, or device fragments remain in patient 1
Total Device Problems 975

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