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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colonoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine or perform procedures in the colon or rectum
Product CodeFDF
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AIZU OLYMPUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
PENTAX
  SUBSTANTIALLY EQUIVALENT 9
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 77
Device Cleaning Issue 41
No Known Device Problem 17
No Information 10
Break 5
Contamination during use 4
Poor quality image 4
Increase in pressure 3
Scratched material 3
Dislodged or dislocated 3
Not Applicable 2
Data Issue 2
Electro-static discharge 2
Unknown (for use when the device problem is not known) 2
Bacterial contamination of device 2
Use of Device Issue 2
Dent in material 2
Spark 2
Loss of power 2
Crack 1
Material rigid or stiff 1
Material separation 1
Smoking 1
Sticking 1
Device inoperable 1
Charred 1
Detachment of device component 1
Entrapment of device or device component 1
Fire 1
Flaked 1
Image display error 1
Difficult to insert 1
Device Contamination with biological material 1
Failure to zero 1
Device contamination with blood or blood product 1
Obstruction within device 1
Foreign material present in device 1
Material deformation 1
Power source issue 1
Bent 1
Total Device Problems 206

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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