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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 151
No Known Device Problem 84
Device Cleaning Issue 75
Bacterial contamination of device 20
No Information 18
Break 10
Foreign material present in device 9
Material deformation 5
Excess flow or overinfusion 5
Poor quality image 5
Use of Device Issue 4
Contamination during use 4
Electro-static discharge 4
Device Issue 4
Disinfection or Sterilization Issue at User Location 4
Device operates differently than expected 4
Difficult to open or close 3
Dislodged or dislocated 3
Dent in material 3
Maintenance does not comply to manufacturers recommendations 3
Material Protrusion 3
Device Contamination with biological material 3
Scratched material 3
Electrical issue 3
Detachment of device component 3
Increase in pressure 3
Device handling issue 3
Data Issue 2
Loss of power 2
Fire 2
Failure to flush 2
Blockage within device or device component 2
Incorrect display 2
Pressure issue 2
Not Applicable 2
Spark 2
Improper flow or infusion 2
Material integrity issue 2
Obstruction within device 2
Unknown (for use when the device problem is not known) 2
Device Rinsing Issue 1
Device contamination with blood or blood product 1
Solder joint failure 1
Sharp/jagged/rough/etched/scratched 1
Delamination 1
Detachment of device or device component 1
Failure to shut off 1
Temperature issue 1
No Pressure 1
Positioning Issue 1
Power source issue 1
EKG/ECG analysis, failure to perform 1
Entrapment of device or device component 1
Corrosion 1
Crack 1
Disconnection 1
Loss of or failure to bond 1
Charred 1
Bent 1
Device clogged 1
Material frayed 1
Image display error 1
Flaked 1
Difficult to insert 1
Mechanical issue 1
Misconnection 1
Failure to zero 1
Difficult to remove 1
Material rigid or stiff 1
Material separation 1
Smoking 1
Sticking 1
Device inoperable 1
Total Device Problems 498

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 3
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
2 Pentax Medical Company II Jul-23-2016
3 Pentax Medical Company II Jun-28-2016

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