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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ligator, hemorrhoidal
Regulation Description Hemorrhoidal ligator.
Product CodeFHN
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
AGENCY FOR MEDICAL INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
THD SPA
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to deploy 127
Premature deployment 81
No code available 55
Failure to separate 54
Break 36
Detachment of device or device component 12
Failure to Adhere or Bond 11
Difficult to deploy 6
Misfire 5
Migration of device or device component 4
Failure to advance 4
Difficult to remove 3
Detachment of device component 3
Material separation 2
Deployment issue 2
Mechanical jam 1
Malfunction 1
Device, removal of (non-implant) 1
Component or accessory incompatibility 1
Fracture 1
Material fragmentation 1
Device abrasion from instrument or another object 1
Total Device Problems 412

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 1 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 Boston Scientific Corporation II Aug-22-2011
2 Boston Scientific Corporation II Sep-02-2009
3 Cook Endoscopy II Oct-19-2010

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