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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 234
Balloon rupture 125
Hole in material 124
Deflation issue 119
Balloon burst 115
Use of Device Issue 89
Difficult to remove 72
Detachment of device component 44
Crack 39
Kinked 32
Inflation issue 30
Balloon leak(s) 28
Leak 27
Foreign material present in device 17
Material deformation 17
Other (for use when an appropriate device code cannot be identified) 17
Break 14
Material fragmentation 14
Bent 14
Improper or incorrect procedure or method 13
Material rupture 13
Material separation 12
Torn material 10
Tears, rips, holes in device, device material 10
Fracture 9
Balloon pinhole 9
Unknown (for use when the device problem is not known) 8
Retraction problem 6
Component missing 6
Difficult to insert 6
User used incorrect product for intended use 6
Normal 6
Unsealed device packaging 5
Material perforation 5
Balloon asymmetrical 4
Device damaged prior to use 4
Device markings issue 4
Incomplete or missing packaging 4
Tear, rip or hole in device packaging 4
Failure to advance 3
Physical resistance 3
Foreign material 3
Device operates differently than expected 3
Material puncture 3
No Known Device Problem 3
Entrapment of device or device component 3
Detachment of device or device component 3
Device expiration issue 2
Deflation, cause unknown 2
Wire(s), breakage of 2
Device or device component damaged by another device 2
Material rigid or stiff 2
Incorrect device or component shipped 2
Difficult to open or close 2
Not Applicable 2
Dislodged or dislocated 2
Loss of or failure to bond 2
No code available 2
Inadequate instructions for healthcare professional 1
Mislabeled 1
Failure to fold 1
Disinfection or Sterilization Issue at User Location 1
Delivered as unsterile product 1
Material twisted 1
Device, or device fragments remain in patient 1
Product quality issue 1
Tip breakage 1
Material integrity issue 1
Blockage within device or device component 1
Difficult to advance 1
Manufacturing or shipping issue associated with device 1
Positioning Issue 1
Delivery system failure 1
Defective item 1
Component(s), broken 1
Packaging issue 1
Total Device Problems 1379

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 2 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 1 0 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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