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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 153
No Known Device Problem 127
Detachment of device component 72
Close, difficult to 60
Device operates differently than expected 57
Difficult to remove 51
Wire(s), breakage of 48
Fracture 44
Normal 26
Dull 23
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
Material separation 11
Difficult to insert 10
Difficult to open or close 9
Electrical issue 8
No Information 8
Retraction problem 7
Device, or device fragments remain in patient 7
Foreign material present in device 7
Component missing 7
Device inoperable 7
Failure to advance 7
Device or device fragments location unknown 6
Source, detachment from 6
Kinked 5
Material fragmentation 5
Failure to cut 5
Detachment of device or device component 5
Packaging issue 5
Human-Device Interface Issue 4
Failure to align 4
Defective component 4
Foreign material 4
Device handling issue 4
Entrapment of device or device component 3
Physical resistance 3
Arcing 2
Failure to obtain samples 2
Device Issue 2
Tear, rip or hole in device packaging 2
Use of Device Issue 2
Fitting problem 2
Material perforation 2
Defective item 2
Loose or intermittent connection 2
Loose 2
Unsealed device packaging 2
Heat, failure to 2
Twisting 2
Failure to sterilize 1
Tip breakage 1
Needle, dull 1
Needle, separation 1
Lens, disc 1
Material frayed 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
Spark 1
Inadequate user interface 1
Incorrect device or component shipped 1
Material integrity issue 1
Scratched material 1
Therapeutic or diagnostic output failure 1
Device markings issue 1
Out-of-box failure 1
Residue after decontamination 1
Split 1
Total Device Problems 1586

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jun-04-2010

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