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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 193
Bacterial contamination of device 147
No Known Device Problem 98
Device Cleaning Issue 86
No Information 18
Foreign material present in device 15
Break 12
Disinfection or Sterilization Issue at User Location 11
Material rigid or stiff 9
Poor quality image 6
Degraded 6
Device Issue 6
Material deformation 6
Detachment of device or device component 5
Mechanical issue 5
Excess flow or overinfusion 5
Contamination during use 4
Device operates differently than expected 4
Obstruction within device 4
Dent in material 4
Electro-static discharge 4
Increase in pressure 4
Use of Device Issue 4
Maintenance does not comply to manufacturers recommendations 4
Leak 3
Scratched material 3
Device handling issue 3
Difficult to open or close 3
Dislodged or dislocated 3
Device Contamination with biological material 3
Material integrity issue 3
Material Protrusion 3
Electrical issue 3
Detachment of device component 3
Device clogged 2
Blockage within device or device component 2
Incorrect display 2
Corrosion 2
Fire 2
Failure to flush 2
Loss of power 2
Material separation 2
Improper flow or infusion 2
Unknown (for use when the device problem is not known) 2
Spark 2
Data Issue 2
Pressure issue 2
Not Applicable 2
No code available 1
Temperature issue 1
Buckled material 1
Connection issue 1
Delamination 1
Failure to zero 1
Difficult to remove 1
Device Rinsing Issue 1
Device contamination with blood or blood product 1
Solder joint failure 1
Failure to shut off 1
Mechanical jam 1
No Pressure 1
Positioning Issue 1
Power source issue 1
Smoking 1
Sticking 1
Device inoperable 1
Misconnection 1
Material frayed 1
Image display error 1
Image resolution poor 1
Flaked 1
Fluid leak 1
Difficult to insert 1
Crack 1
Disconnection 1
EKG/ECG analysis, failure to perform 1
Entrapment of device or device component 1
Loss of or failure to bond 1
Charred 1
Bent 1
Total Device Problems 750

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 4 0
Class III 0 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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