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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic access overtube, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Product CodeFED
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
APOLLO CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTC INC.-MEMCATH TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
SPIRUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Break 36
Tip breakage 17
No Known Device Problem 11
Torn material 9
Difficult to remove 8
Peeled 6
Device, or device fragments remain in patient 6
Fracture 5
Detachment of device component 4
Normal 4
Blockage within device or device component 3
Material perforation 3
Foreign material present in device 3
Detachment of device or device component 2
No Information 2
No code available 2
Difficult to insert 2
Misconnection 1
Inflation issue 1
Deflation issue 1
Flaked 1
Burn of device or device component 1
Material separation 1
Improper or incorrect procedure or method 1
Unknown (for use when the device problem is not known) 1
Device handling issue 1
Device packaging compromised 1
Improper flow or infusion 1
Bacterial contamination of device 1
Structural problem 1
Delamination 1
Total Device Problems 137

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 1 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-04-2013
2 Cook Urological, Inc. II Jan-25-2007

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