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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 179
Premature deployment 99
Failure to separate 58
No code available 55
Break 44
Failure to Adhere or Bond 15
Detachment of device or device component 13
Difficult to deploy 9
Misfire 5
Failure to advance 4
Migration of device or device component 4
Difficult to remove 3
Detachment of device component 3
Material separation 2
Deployment issue 2
Device abrasion from instrument or another object 1
No Known Device Problem 1
Fracture 1
Material fragmentation 1
Mechanical jam 1
Component or accessory incompatibility 1
Device, removal of (non-implant) 1
Malfunction 1
Total Device Problems 503

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 1 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 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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