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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic cytology brush
Regulation Description Endoscope and accessories.
Definition To collect cells for cytological evaluation.
Product CodeFDX
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Retraction problem 42
Bent 25
Detachment of device component 17
Break 16
No Known Device Problem 13
Failure to advance 6
Torn material 5
Patient-device incompatibility 5
Detachment of device or device component 5
Foreign material 5
Fracture 4
Wire(s), breakage of 4
Tears, rips, holes in device, device material 3
Kinked 3
Device, or device fragments remain in patient 3
Difficult to remove 2
Material separation 2
Source, detachment from 2
Mislabeled 2
Difficult to position 2
Blockage within device or device component 2
Use of Device Issue 2
Other (for use when an appropriate device code cannot be identified) 2
Device damaged prior to use 2
Split 1
Physical resistance 1
Difficult to advance 1
Device handling issue 1
Migration of device or device component 1
Difficult to insert 1
User used incorrect product for intended use 1
Unsealed device packaging 1
Total Device Problems 182

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 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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