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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
No code available 185
Other (for use when an appropriate device code cannot be identified) 160
Break 155
No Known Device Problem 139
Detachment of device component 73
Close, difficult to 60
Device operates differently than expected 59
Difficult to remove 51
Wire(s), breakage of 48
Fracture 44
Normal 26
Dull 23
Material Protrusion 21
Unknown (for use when the device problem is not known) 21
Device damaged prior to use 19
Mechanical issue 18
Component(s), broken 17
Mechanical jam 17
Material separation 16
Difficult to open or close 11
Difficult to insert 10
Foreign material present in device 9
No Information 8
Electrical issue 8
Retraction problem 7
Component missing 7
Device, or device fragments remain in patient 7
Failure to advance 7
Device inoperable 7
Source, detachment from 6
Device or device fragments location unknown 6
Detachment of device or device component 5
Failure to align 5
Packaging issue 5
Kinked 5
Material fragmentation 5
Device handling issue 5
Failure to cut 5
Defective component 4
Human-Device Interface Issue 4
Foreign material 4
Physical resistance 3
Entrapment of device or device component 3
Loose or intermittent connection 2
Material perforation 2
Defective item 2
Heat, failure to 2
Unsealed device packaging 2
Device Issue 2
Arcing 2
Loose 2
Fitting problem 2
Failure to obtain samples 2
Tear, rip or hole in device packaging 2
Use of Device Issue 2
Twisting 2
Material frayed 1
Difficult to deploy 1
Residue after decontamination 1
Therapeutic or diagnostic output failure 1
Balloon rupture 1
Tip breakage 1
Material integrity issue 1
Contamination during use 1
Spark 1
Failure to sterilize 1
Energy output to patient tissue incorrect 1
Incorrect device or component shipped 1
Needle, separation 1
Failure to deliver energy 1
Lens, disc 1
Out-of-box failure 1
Collapse 1
Split 1
Inadequate user interface 1
Needle, dull 1
Burn of device or device component 1
Disconnection 1
Scratched material 1
Device markings issue 1
Total Device Problems 1615

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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