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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 8
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 208
Balloon rupture 125
Balloon burst 115
Deflation issue 106
Hole in material 98
Difficult to remove 70
Use of Device Issue 60
Kinked 32
Detachment of device component 31
Inflation issue 30
Crack 29
Balloon leak(s) 28
Leak 19
Foreign material present in device 17
Other (for use when an appropriate device code cannot be identified) 17
Material deformation 15
Bent 14
Improper or incorrect procedure or method 12
Material separation 12
Material fragmentation 12
Break 10
Torn material 10
Tears, rips, holes in device, device material 10
Material rupture 9
Balloon pinhole 9
Fracture 8
Unknown (for use when the device problem is not known) 8
Component missing 6
Retraction problem 6
Difficult to insert 6
Normal 6
Unsealed device packaging 5
User used incorrect product for intended use 4
Incomplete or missing packaging 4
Device markings issue 4
Balloon asymmetrical 4
Detachment of device or device component 3
Material perforation 3
Device damaged prior to use 3
Material puncture 3
Foreign material 3
Physical resistance 3
Failure to advance 3
Tear, rip or hole in device packaging 2
Not Applicable 2
No code available 2
Difficult to open or close 2
No Known Device Problem 2
Deflation, cause unknown 2
Entrapment of device or device component 2
Device expiration issue 2
Wire(s), breakage of 2
Material rigid or stiff 2
Incorrect device or component shipped 2
Blockage within device or device component 1
Component(s), broken 1
Defective item 1
Delivery system failure 1
Packaging issue 1
Difficult to advance 1
Manufacturing or shipping issue associated with device 1
Positioning Issue 1
Failure to fold 1
Delivered as unsterile product 1
Dislodged or dislocated 1
Inadequate instructions for healthcare professional 1
Mislabeled 1
Loss of or failure to bond 1
Product quality issue 1
Tip breakage 1
Material integrity issue 1
Device, or device fragments remain in patient 1
Device operates differently than expected 1
Material twisted 1
Total Device Problems 1222

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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