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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 231
Balloon rupture 125
Hole in material 122
Balloon burst 115
Deflation issue 115
Use of Device Issue 84
Difficult to remove 72
Detachment of device component 38
Crack 36
Kinked 32
Inflation issue 30
Balloon leak(s) 28
Leak 24
Other (for use when an appropriate device code cannot be identified) 17
Foreign material present in device 17
Material deformation 16
Bent 14
Break 13
Material fragmentation 13
Improper or incorrect procedure or method 13
Material rupture 12
Material separation 12
Tears, rips, holes in device, device material 10
Torn material 10
Balloon pinhole 9
Unknown (for use when the device problem is not known) 8
Fracture 8
Normal 6
User used incorrect product for intended use 6
Difficult to insert 6
Retraction problem 6
Component missing 6
Material perforation 5
Unsealed device packaging 5
Balloon asymmetrical 4
Device damaged prior to use 4
Tear, rip or hole in device packaging 4
Incomplete or missing packaging 4
Device markings issue 4
Device operates differently than expected 3
No Known Device Problem 3
Failure to advance 3
Physical resistance 3
Foreign material 3
Entrapment of device or device component 3
Material puncture 3
Detachment of device or device component 3
Not Applicable 2
No code available 2
Device expiration issue 2
Deflation, cause unknown 2
Material rigid or stiff 2
Incorrect device or component shipped 2
Difficult to open or close 2
Dislodged or dislocated 2
Device or device component damaged by another device 2
Wire(s), breakage of 2
Disinfection or Sterilization Issue at User Location 1
Delivery system failure 1
Difficult to advance 1
Manufacturing or shipping issue associated with device 1
Packaging issue 1
Positioning Issue 1
Material integrity issue 1
Material twisted 1
Tip breakage 1
Defective item 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 1347

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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