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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 162
No Known Device Problem 91
Device Cleaning Issue 76
Bacterial contamination of device 26
No Information 18
Foreign material present in device 11
Break 11
Device Issue 6
Material deformation 5
Excess flow or overinfusion 5
Poor quality image 5
Use of Device Issue 4
Contamination during use 4
Device operates differently than expected 4
Electro-static discharge 4
Disinfection or Sterilization Issue at User Location 4
Dent in material 4
Device Contamination with biological material 3
Difficult to open or close 3
Dislodged or dislocated 3
Maintenance does not comply to manufacturers recommendations 3
Material Protrusion 3
Scratched material 3
Electrical issue 3
Detachment of device component 3
Increase in pressure 3
Device handling issue 3
Data Issue 2
Pressure issue 2
Not Applicable 2
Loss of power 2
Fire 2
Failure to flush 2
Blockage within device or device component 2
Incorrect display 2
Material integrity issue 2
Improper flow or infusion 2
Spark 2
Unknown (for use when the device problem is not known) 2
Obstruction within device 2
Device Rinsing Issue 1
Device contamination with blood or blood product 1
Solder joint failure 1
Sharp/jagged/rough/etched/scratched 1
Connection issue 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 530

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 4
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
4 Pentax of America Inc II Nov-19-2016

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