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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 601
Failure to deploy 589
Premature deployment 358
Failure to advance 290
Failure to disconnect 270
Other (for use when an appropriate device code cannot be identified) 250
Material separation 164
Detachment of device component 164
No code available 134
Break 100
Misfire 100
Bent 92
Difficult to deploy 87
Device maintenance issue 76
Fracture 75
Migration of device or device component 49
Component(s), broken 46
Kinked 22
Close, difficult to 22
Mechanical issue 20
No Known Device Problem 19
Difficult to open or close 17
Improper or incorrect procedure or method 12
Component missing 11
User used incorrect product for intended use 11
Failure to fire 11
Difficult to remove 10
Failure to Adhere or Bond 9
Device inoperable 9
Suction issue 8
Unknown (for use when the device problem is not known) 8
Device Issue 8
Excessive Manipulation 8
Difficult to position 8
Malposition of device 8
Deployment issue 7
Detachment of device or device component 7
Device, or device fragments remain in patient 7
Device-device incompatibility 6
No Information 6
Mechanical jam 5
Dislodged or dislocated 5
Fitting problem 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
Shelf life exceeded 4
Source, detachment from 3
Vacuum, loss of 3
Device damaged prior to use 3
Cut in material 3
Misassembled 3
Normal 3
Device operates differently than expected 3
Torn material 3
Device, removal of (non-implant) 2
Lens (IOL), defective, problem not specified 2
Loose 2
Decrease in suction 2
Accessory incompatible 2
pH, low 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
Unstable 1
Twisting 1
Seal, defective 1
Failure to align 1
Inaccurate delivery 1
Malfunction 1
Device or device fragments location unknown 1
Physical resistance 1
Increased sensitivity 1
Split 1
Abnormal 1
Loss of or failure to bond 1
Cautery 1
Deflation issue 1
Fluid leak 1
Foreign material 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
Device packaging compromised 1
Difficult to advance 1
Material Protrusion 1
Material twisted 1
Device handling issue 1
Total Device Problems 3827

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 1 0 0 0 0 0
Class III 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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