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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 130
No Known Device Problem 73
Device Cleaning Issue 66
No Information 18
Bacterial contamination of device 17
Break 10
Foreign material present in device 9
Material deformation 5
Poor quality image 5
Contamination during use 4
Electro-static discharge 4
Disinfection or Sterilization Issue at User Location 4
Use of Device Issue 4
Difficult to open or close 3
Dislodged or dislocated 3
Maintenance does not comply to manufacturers recommendations 3
Increase in pressure 3
Electrical issue 3
Dent in material 3
Detachment of device component 3
Device Contamination with biological material 3
Excess flow or overinfusion 3
Material Protrusion 3
Scratched material 3
Incorrect display 2
Failure to flush 2
Improper flow or infusion 2
Loss of power 2
Pressure issue 2
Not Applicable 2
Unknown (for use when the device problem is not known) 2
Obstruction within device 2
Material integrity issue 2
Data Issue 2
Spark 2
Device operates differently than expected 2
Fire 2
Difficult to remove 1
Bent 1
Power source issue 1
Device contamination with blood or blood product 1
Solder joint failure 1
Corrosion 1
Misconnection 1
Device inoperable 1
Delamination 1
Loss of or failure to bond 1
Smoking 1
Material frayed 1
No Pressure 1
Image display error 1
Sharp/jagged/rough/etched/scratched 1
Sticking 1
Failure to zero 1
Material rigid or stiff 1
Material separation 1
Device Issue 1
Device handling issue 1
Device clogged 1
EKG/ECG analysis, failure to perform 1
Temperature issue 1
Detachment of device or device component 1
Failure to shut off 1
Mechanical issue 1
Charred 1
Crack 1
Entrapment of device or device component 1
Flaked 1
Difficult to insert 1
Positioning Issue 1
Total Device Problems 441

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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