• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 603
Premature deployment 391
Failure to advance 290
Failure to disconnect 270
Other (for use when an appropriate device code cannot be identified) 250
Detachment of device component 183
Material separation 171
No code available 134
Difficult to deploy 109
Break 104
Misfire 100
Bent 92
Fracture 84
Device maintenance issue 76
Migration of device or device component 57
Component(s), broken 46
Improper or incorrect procedure or method 23
Kinked 22
No Known Device Problem 22
Close, difficult to 22
Mechanical issue 20
Device operates differently than expected 18
Difficult to open or close 17
Deployment issue 13
Failure to fire 11
User used incorrect product for intended use 11
Component missing 11
Device Issue 10
Difficult to remove 10
Difficult to position 10
Failure to Adhere or Bond 9
Device inoperable 9
Suction issue 8
Unknown (for use when the device problem is not known) 8
Excessive Manipulation 8
Malposition of device 8
Device-device incompatibility 8
Detachment of device or device component 7
Device, or device fragments remain in patient 7
No Information 6
Mechanical jam 5
Dislodged or dislocated 5
Wire(s), breakage of 5
Failure to deliver 5
Fitting problem 5
Shelf life exceeded 5
Dislodged 5
Entrapment of device or device component 5
Device expiration issue 5
Component falling 4
Difficult to insert 4
Defective item 4
Incompatibility problem 3
Torn material 3
Misassembled 3
Normal 3
Source, detachment from 3
Use of Device Issue 3
Vacuum, loss of 3
Device damaged prior to use 3
Cut in material 3
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
Loose 2
Decrease in suction 2
Accessory incompatible 2
Device, removal of (non-implant) 2
Lens (IOL), defective, problem not specified 2
Component or accessory incompatibility 1
Device or device fragments location unknown 1
Device misassembled during manufacturing or shipping 1
Material Protrusion 1
Material twisted 1
Difficult to advance 1
Device packaging compromised 1
Device handling issue 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
Unstable 1
Twisting 1
Seal, defective 1
Physical resistance 1
Increased sensitivity 1
Split 1
Total Device Problems 4008

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

-
-