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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 13
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 146
No Known Device Problem 78
Device Cleaning Issue 68
Bacterial contamination of device 18
No Information 18
Break 10
Foreign material present in device 9
Material deformation 5
Poor quality image 5
Excess flow or overinfusion 5
Use of Device Issue 4
Contamination during use 4
Electro-static discharge 4
Disinfection or Sterilization Issue at User Location 4
Dent in material 3
Detachment of device component 3
Maintenance does not comply to manufacturers recommendations 3
Device Contamination with biological material 3
Device operates differently than expected 3
Difficult to open or close 3
Dislodged or dislocated 3
Material Protrusion 3
Scratched material 3
Device handling issue 3
Electrical issue 3
Increase in pressure 3
Loss of power 2
Incorrect display 2
Fire 2
Failure to flush 2
Not Applicable 2
Data Issue 2
Pressure issue 2
Material integrity issue 2
Spark 2
Improper flow or infusion 2
Obstruction within device 2
Unknown (for use when the device problem is not known) 2
Sharp/jagged/rough/etched/scratched 1
Delamination 1
Detachment of device or device component 1
Failure to shut off 1
No Pressure 1
Positioning Issue 1
Power source issue 1
Temperature issue 1
Material frayed 1
Image display error 1
Flaked 1
EKG/ECG analysis, failure to perform 1
Entrapment of device or device component 1
Corrosion 1
Crack 1
Device clogged 1
Charred 1
Bent 1
Loss of or failure to bond 1
Failure to zero 1
Device Rinsing Issue 1
Device contamination with blood or blood product 1
Solder joint failure 1
Device Issue 1
Difficult to remove 1
Material rigid or stiff 1
Material separation 1
Smoking 1
Sticking 1
Device inoperable 1
Difficult to insert 1
Mechanical issue 1
Misconnection 1
Total Device Problems 471

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

Recalls
Manufacturer Recall Class Date Posted
1 EndoChoice, Inc. II Jan-27-2016

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