• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 170
No Known Device Problem 92
Device Cleaning Issue 76
Bacterial contamination of device 58
No Information 18
Break 13
Foreign material present in device 12
Material deformation 6
Device Issue 6
Excess flow or overinfusion 5
Poor quality image 5
Dent in material 4
Detachment of device or device component 4
Device operates differently than expected 4
Contamination during use 4
Electro-static discharge 4
Disinfection or Sterilization Issue at User Location 4
Use of Device Issue 4
Maintenance does not comply to manufacturers recommendations 3
Dislodged or dislocated 3
Difficult to open or close 3
Electrical issue 3
Increase in pressure 3
Scratched material 3
Detachment of device component 3
Device Contamination with biological material 3
Device handling issue 3
Material Protrusion 3
Loss of power 2
Device clogged 2
Material separation 2
Blockage within device or device component 2
Pressure issue 2
Failure to flush 2
Improper flow or infusion 2
Incorrect display 2
Not Applicable 2
Obstruction within device 2
Unknown (for use when the device problem is not known) 2
Material integrity issue 2
Data Issue 2
Spark 2
Fire 2
Bent 1
Difficult to remove 1
Power source issue 1
Solder joint failure 1
Corrosion 1
Image resolution poor 1
Device contamination with blood or blood product 1
Misconnection 1
Device inoperable 1
Smoking 1
Delamination 1
Loss of or failure to bond 1
Material frayed 1
Connection issue 1
Crack 1
Charred 1
Mechanical issue 1
Failure to shut off 1
Fluid leak 1
Temperature issue 1
Flaked 1
Entrapment of device or device component 1
Difficult to insert 1
Device Rinsing Issue 1
Positioning Issue 1
Disconnection 1
Sharp/jagged/rough/etched/scratched 1
Image display error 1
No Pressure 1
Failure to zero 1
Sticking 1
Material rigid or stiff 1
EKG/ECG analysis, failure to perform 1
Total Device Problems 582

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

-
-