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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
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 34
Tip breakage 17
No Known Device Problem 9
Difficult to remove 8
Device, or device fragments remain in patient 6
Detachment of device component 4
Normal 4
Peeled 3
Material perforation 3
Detachment of device or device component 2
No Information 2
Difficult to insert 2
Foreign material present in device 2
Blockage within device or device component 2
Material separation 1
Device handling issue 1
Burn of device or device component 1
Flaked 1
Improper flow or infusion 1
Torn material 1
Bacterial contamination of device 1
Fracture 1
Improper or incorrect procedure or method 1
Misconnection 1
Unknown (for use when the device problem is not known) 1
Structural problem 1
Total Device Problems 110

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