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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, esophageal
Regulation Description Esophageal dilator.
Product CodeKNQ
Regulation Number 876.5365
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KEYMED
  SUBSTANTIALLY EQUIVALENT 1
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Burst 218
Balloon rupture 125
Balloon burst 115
Hole in material 113
Deflation issue 111
Use of Device Issue 73
Difficult to remove 70
Detachment of device component 33
Crack 32
Kinked 32
Inflation issue 30
Balloon leak(s) 28
Leak 19
Other (for use when an appropriate device code cannot be identified) 17
Foreign material present in device 17
Material deformation 15
Bent 14
Material fragmentation 13
Break 12
Improper or incorrect procedure or method 12
Material separation 12
Tears, rips, holes in device, device material 10
Torn material 10
Material rupture 10
Balloon pinhole 9
Unknown (for use when the device problem is not known) 8
Fracture 8
Retraction problem 6
Normal 6
Difficult to insert 6
Component missing 6
Unsealed device packaging 5
User used incorrect product for intended use 4
Balloon asymmetrical 4
Incomplete or missing packaging 4
Material perforation 4
Device markings issue 4
Device operates differently than expected 3
Detachment of device or device component 3
No Known Device Problem 3
Device damaged prior to use 3
Failure to advance 3
Physical resistance 3
Foreign material 3
Material puncture 3
Material rigid or stiff 2
Deflation, cause unknown 2
Entrapment of device or device component 2
Device expiration issue 2
Wire(s), breakage of 2
Tear, rip or hole in device packaging 2
Not Applicable 2
No code available 2
Incorrect device or component shipped 2
Difficult to open or close 2
Dislodged or dislocated 1
Device or device component damaged by another device 1
Difficult to advance 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Material twisted 1
Packaging issue 1
Positioning Issue 1
Defective item 1
Delivery system failure 1
Tip breakage 1
Failure to fold 1
Component(s), broken 1
Blockage within device or device component 1
Loss of or failure to bond 1
Product quality issue 1
Device, or device fragments remain in patient 1
Inadequate instructions for healthcare professional 1
Mislabeled 1
Delivered as unsterile product 1
Total Device Problems 1279

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 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation III Jul-10-2013
2 Conmed Endoscopic Technologies, Inc. II Jun-19-2007
3 Cook Endoscopy II Feb-22-2007

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