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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic ultrasound system, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To provide ultrasonic visualization of body cavities that can be accessed by endoscope.
Product CodeODG
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 7
PENTAX
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
No Known Device Problem 15
Detachment of device or device component 5
Device Cleaning Issue 5
Device markings issue 4
Disinfection or Sterilization Issue at User Location 2
No display or display failure 2
Leak 1
Unsealed device packaging 1
Difficult to position 1
Material puncture 1
Material separation 1
Device contamination with blood or blood product 1
Failure to align 1
Break 1
Scratched material 1
No Information 1
Device operates differently than expected 1
Device packaging compromised 1
Foreign material present in device 1
Total Device Problems 46

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

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Sep-28-2015
2 Pentax Medical Company II Jul-23-2016

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