• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 5

Device Problems
Break 237
Misfire 161
Retraction problem 126
Loose 89
Bent 82
No Known Device Problem 44
Unknown (for use when the device problem is not known) 35
Occlusion within device 31
Difficult to remove 25
Other (for use when an appropriate device code cannot be identified) 22
Difficult to advance 20
Unstable 19
Material puncture 19
Detachment of device component 19
Kinked 18
Tear, rip or hole in device packaging 17
Material separation 15
Detachment of device or device component 13
Tip breakage 10
Fracture 10
Device markings issue 8
Failure to obtain samples 8
No code available 8
Failure to fire 7
Needle, separation 7
Failure to advance 6
Device Issue 5
Material perforation 5
Locking mechanism failure 4
Failure to deploy 4
Blockage within device or device component 3
Component(s), broken 3
Material fragmentation 3
Needle, unsheathed 3
Sticking 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Device-device incompatibility 3
No Information 2
Device handling issue 2
Fitting problem 2
Device damaged prior to use 2
Defective component 2
Malfunction 2
Physical resistance 2
Device or device fragments location unknown 2
Foreign material present in device 2
Difficult to deploy 2
Dislodged 1
Fluid leak 1
Loss of or failure to bond 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
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanical jam 1
Dislodged or dislocated 1
Catheter withdrawal interference 1
Wrinkled 1
Deployment issue 1
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Obstruction within device 1
Seal, defective 1
Packaging issue 1
Total Device Problems 1148

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 1
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 Medtronic II Feb-28-2017
10 Olympus America Inc. II Oct-07-2011

-
-