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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ligator, esophageal
Regulation Description Hemorrhoidal ligator.
Product CodeMND
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to separate 616
Failure to deploy 593
Premature deployment 368
Failure to advance 290
Failure to disconnect 270
Other (for use when an appropriate device code cannot be identified) 250
Detachment of device component 175
Material separation 169
No code available 134
Break 104
Misfire 100
Difficult to deploy 99
Bent 92
Fracture 83
Device maintenance issue 76
Migration of device or device component 56
Component(s), broken 46
Kinked 22
Close, difficult to 22
No Known Device Problem 21
Mechanical issue 20
Difficult to open or close 17
Improper or incorrect procedure or method 14
Component missing 11
User used incorrect product for intended use 11
Failure to fire 11
Deployment issue 10
Difficult to remove 10
Difficult to position 10
Device Issue 10
Device inoperable 9
Failure to Adhere or Bond 9
Device operates differently than expected 9
Malposition of device 8
Suction issue 8
Unknown (for use when the device problem is not known) 8
Excessive Manipulation 8
Device, or device fragments remain in patient 7
Detachment of device or device component 7
Device-device incompatibility 6
No Information 6
Mechanical jam 5
Dislodged or dislocated 5
Fitting problem 5
Shelf life exceeded 5
Failure to deliver 5
Wire(s), breakage of 5
Dislodged 5
Device expiration issue 5
Component falling 4
Difficult to insert 4
Defective item 4
Cut in material 3
Source, detachment from 3
Vacuum, loss of 3
Device damaged prior to use 3
Misassembled 3
Normal 3
Torn material 3
Incompatibility problem 2
Device, removal of (non-implant) 2
Lens (IOL), defective, problem not specified 2
Loose 2
Decrease in suction 2
Entrapment of device or device component 2
Accessory incompatible 2
Defective component 2
Sticking 2
Stretched 2
Suture line separation 2
Tears, rips, holes in device, device material 2
Slippage of device or device component 2
pH, low 2
Failure to align 1
Inaccurate delivery 1
Malfunction 1
Device or device fragments location unknown 1
Physical resistance 1
Increased sensitivity 1
Split 1
Unstable 1
Twisting 1
Seal, defective 1
Abnormal 1
Loss of or failure to bond 1
Cautery 1
Fluid leak 1
Foreign material 1
Deflation issue 1
Inability to irrigate 1
Material fragmentation 1
Handpiece break 1
Replace 1
Retraction problem 1
Material puncture 1
Component or accessory incompatibility 1
Device misassembled during manufacturing or shipping 1
Material Protrusion 1
Material twisted 1
Difficult to advance 1
Total Device Problems 3923

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

Recalls
Manufacturer Recall Class Date Posted
1 Cook Endoscopy II Jun-28-2011
2 Cook Endoscopy II Oct-19-2010

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