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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lithotriptor, electro-hydraulic
Regulation Description Electrohydraulic lithotriptor.
Product CodeFFK
Regulation Number 876.4480
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
LARYNGEAL MASK
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISPEC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 10
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fracture 22
Break 8
Component(s), broken 5
Metal shedding debris 4
Tear, rip or hole in device packaging 4
Failure to align 3
Difficult to remove 3
Defective component 2
Delivered as unsterile product 2
Normal 2
No Information 2
Bent 2
No code available 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Device packaging compromised 1
Foreign material present in device 1
Unsealed device packaging 1
Device, or device fragments remain in patient 1
Detachment of device component 1
Crack 1
Material fragmentation 1
Insulation failure 1
Source, detachment from 1
Sterility 1
Tears, rips, holes in device, device material 1
Tip breakage 1
Device inoperable 1
Use of Device Issue 1
Total Device Problems 76

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 2 0 1 0 0 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 Corp II Nov-11-2009
2 E.M.S. - Electro Medical Systems SA II Mar-30-2007
3 Gyrus ACMI Corporation II Aug-09-2007

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