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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 615
Failure to deploy 593
Premature deployment 367
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 103
Misfire 100
Difficult to deploy 97
Bent 92
Fracture 83
Device maintenance issue 76
Migration of device or device component 55
Component(s), broken 46
Close, difficult to 22
Kinked 22
No Known Device Problem 21
Mechanical issue 20
Difficult to open or close 17
Improper or incorrect procedure or method 14
Failure to fire 11
Component missing 11
User used incorrect product for intended use 11
Difficult to position 10
Deployment issue 10
Difficult to remove 10
Failure to Adhere or Bond 9
Device inoperable 9
Device Issue 9
Malposition of device 8
Device operates differently than expected 8
Unknown (for use when the device problem is not known) 8
Suction issue 8
Excessive Manipulation 8
Device, or device fragments remain in patient 7
Detachment of device or device component 7
No Information 6
Device-device incompatibility 6
Dislodged 5
Fitting problem 5
Mechanical jam 5
Wire(s), breakage of 5
Shelf life exceeded 5
Device expiration issue 5
Failure to deliver 5
Dislodged or dislocated 5
Defective item 4
Component falling 4
Difficult to insert 4
Device damaged prior to use 3
Torn material 3
Source, detachment from 3
Cut in material 3
Vacuum, loss of 3
Normal 3
Misassembled 3
pH, low 2
Tears, rips, holes in device, device material 2
Incompatibility problem 2
Lens (IOL), defective, problem not specified 2
Defective component 2
Suture line separation 2
Sticking 2
Device, removal of (non-implant) 2
Loose 2
Accessory incompatible 2
Slippage of device or device component 2
Stretched 2
Decrease in suction 2
Entrapment of device or device component 2
Difficult to advance 1
Inability to irrigate 1
Malfunction 1
Fluid leak 1
Split 1
Inaccurate delivery 1
Failure to align 1
Device or device fragments location unknown 1
Device misassembled during manufacturing or shipping 1
Seal, defective 1
Component or accessory incompatibility 1
Material fragmentation 1
Device packaging compromised 1
Device handling issue 1
Material Protrusion 1
Handpiece break 1
Unstable 1
Increased sensitivity 1
Physical resistance 1
Foreign material 1
Material twisted 1
Twisting 1
Replace 1
Abnormal 1
Loss of or failure to bond 1
Cautery 1
Material puncture 1
Total Device Problems 3915

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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