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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 267
Hole in material 146
Deflation issue 130
Balloon rupture 125
Balloon burst 115
Use of Device Issue 112
Difficult to remove 76
Detachment of device component 59
Crack 58
Material rupture 43
Leak 39
Kinked 35
Inflation issue 33
Balloon leak(s) 28
Material deformation 24
Bent 23
Improper or incorrect procedure or method 20
Material fragmentation 18
Other (for use when an appropriate device code cannot be identified) 17
Foreign material present in device 17
Break 16
Material separation 14
User used incorrect product for intended use 13
Torn material 12
Tear, rip or hole in device packaging 11
Tears, rips, holes in device, device material 10
Balloon pinhole 9
Fracture 9
Unknown (for use when the device problem is not known) 8
Retraction problem 6
Component missing 6
No Known Device Problem 6
Difficult to insert 6
Normal 6
Unsealed device packaging 5
Material perforation 5
Device damaged prior to use 4
Incomplete or missing packaging 4
Detachment of device or device component 4
Device markings issue 4
Balloon asymmetrical 4
Entrapment of device or device component 3
Material puncture 3
Foreign material 3
Device operates differently than expected 3
Device or device component damaged by another device 3
Failure to advance 3
Physical resistance 3
Wire(s), breakage of 2
Material rigid or stiff 2
Difficult to open or close 2
Dislodged or dislocated 2
Incorrect device or component shipped 2
Device expiration issue 2
Deflation, cause unknown 2
Loss of or failure to bond 2
Not Applicable 2
No code available 2
Delivered as unsterile product 2
Blockage within device or device component 1
Component(s), broken 1
Failure to fold 1
Inadequate instructions for healthcare professional 1
Product quality issue 1
Device, or device fragments remain in patient 1
Mislabeled 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Material twisted 1
Packaging issue 1
Positioning Issue 1
Pressure issue 1
Difficult to advance 1
Device misassembled during manufacturing or shipping 1
Disinfection or Sterilization Issue at User Location 1
Delivery system failure 1
Defective item 1
Tip breakage 1
Total Device Problems 1609

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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