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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 245
Hole in material 132
Balloon rupture 125
Deflation issue 122
Balloon burst 115
Use of Device Issue 98
Difficult to remove 72
Detachment of device component 50
Crack 48
Kinked 34
Inflation issue 31
Leak 28
Balloon leak(s) 28
Material deformation 19
Foreign material present in device 17
Material fragmentation 17
Other (for use when an appropriate device code cannot be identified) 17
Improper or incorrect procedure or method 16
Bent 15
Break 14
Material rupture 13
Material separation 12
Tears, rips, holes in device, device material 10
Torn material 10
Tear, rip or hole in device packaging 9
Balloon pinhole 9
Fracture 9
User used incorrect product for intended use 8
Unknown (for use when the device problem is not known) 8
Retraction problem 6
Component missing 6
Normal 6
Difficult to insert 6
Unsealed device packaging 5
Material perforation 5
No Known Device Problem 5
Device damaged prior to use 4
Incomplete or missing packaging 4
Device markings issue 4
Balloon asymmetrical 4
Entrapment of device or device component 3
Foreign material 3
Material puncture 3
Detachment of device or device component 3
Device operates differently than expected 3
Failure to advance 3
Physical resistance 3
Material rigid or stiff 2
Device or device component damaged by another device 2
Difficult to open or close 2
Dislodged or dislocated 2
Incorrect device or component shipped 2
Wire(s), breakage of 2
Device expiration issue 2
Deflation, cause unknown 2
Loss of or failure to bond 2
Not Applicable 2
No code available 2
Packaging issue 1
Positioning Issue 1
Blockage within device or device component 1
Component(s), broken 1
Failure to fold 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
Disinfection or Sterilization Issue at User Location 1
Delivery system failure 1
Device misassembled during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Material twisted 1
Difficult to advance 1
Tip breakage 1
Defective item 1
Total Device Problems 1448

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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