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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 97
Premature deployment 72
No code available 55
Failure to separate 53
Break 26
Detachment of device or device component 11
Difficult to deploy 6
Failure to Adhere or Bond 4
Failure to advance 4
Migration of device or device component 4
Misfire 3
Difficult to remove 3
Material separation 2
Detachment of device component 2
Deployment issue 2
Mechanical jam 1
Fracture 1
Material fragmentation 1
Device abrasion from instrument or another object 1
Malfunction 1
Device, removal of (non-implant) 1
Component or accessory incompatibility 1
Total Device Problems 351

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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