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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, biopsy, non-electric
Regulation Description Gastroenterology-urology biopsy instrument.
Product CodeFCL
Regulation Number 876.1075
Device Class 1


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SPECTRASCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Bent 267
Device operates differently than expected 198
No code available 185
Other (for use when an appropriate device code cannot be identified) 160
Break 157
No Known Device Problem 148
Detachment of device component 73
Close, difficult to 60
Difficult to remove 51
Wire(s), breakage of 48
Fracture 44
Normal 26
Material separation 26
Dull 26
Unknown (for use when the device problem is not known) 21
Material Protrusion 21
Device damaged prior to use 19
Mechanical issue 18
Component(s), broken 17
Mechanical jam 17
Difficult to open or close 11
Difficult to insert 10
Foreign material present in device 9
Electrical issue 8
No Information 8
Device handling issue 7
Device, or device fragments remain in patient 7
Failure to advance 7
Component missing 7
Retraction problem 7
Device inoperable 7
Failure to align 6
Failure to cut 6
Device or device fragments location unknown 6
Source, detachment from 6
Kinked 5
Material fragmentation 5
Detachment of device or device component 5
Packaging issue 5
Human-Device Interface Issue 4
Defective component 4
Foreign material 4
Entrapment of device or device component 3
Physical resistance 3
Arcing 2
Failure to obtain samples 2
Defective item 2
Device Issue 2
Tear, rip or hole in device packaging 2
Use of Device Issue 2
Material perforation 2
Twisting 2
Fitting problem 2
Loose or intermittent connection 2
Loose 2
Unsealed device packaging 2
Heat, failure to 2
Needle, dull 1
Needle, separation 1
Failure to sterilize 1
Tip breakage 1
Premature deployment 1
User used incorrect product for intended use 1
Lens, disc 1
Material frayed 1
Energy output to patient tissue incorrect 1
Failure to deliver energy 1
Balloon rupture 1
Contamination during use 1
Difficult to deploy 1
Disconnection 1
Burn of device or device component 1
Collapse 1
Improper or incorrect procedure or method 1
Out-of-box failure 1
Residue after decontamination 1
Spark 1
Split 1
Inadequate user interface 1
Incorrect device or component shipped 1
Material integrity issue 1
Device markings issue 1
Scratched material 1
Therapeutic or diagnostic output failure 1
Total Device Problems 1785

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jun-04-2010
2 Cook Inc. II Aug-22-2016

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