• 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 182
No Known Device Problem 93
Bacterial contamination of device 89
Device Cleaning Issue 78
No Information 18
Break 12
Foreign material present in device 12
Material deformation 6
Device Issue 6
Disinfection or Sterilization Issue at User Location 6
Excess flow or overinfusion 5
Poor quality image 5
Contamination during use 4
Electro-static discharge 4
Obstruction within device 4
Dent in material 4
Increase in pressure 4
Use of Device Issue 4
Detachment of device or device component 4
Device operates differently than expected 4
Maintenance does not comply to manufacturers recommendations 4
Scratched material 3
Device handling issue 3
Difficult to open or close 3
Dislodged or dislocated 3
Device Contamination with biological material 3
Material Protrusion 3
Electrical issue 3
Detachment of device component 3
Leak 3
Loss of power 2
Material separation 2
Fire 2
Failure to flush 2
Device clogged 2
Blockage within device or device component 2
Incorrect display 2
Corrosion 2
Material integrity issue 2
Improper flow or infusion 2
Spark 2
Unknown (for use when the device problem is not known) 2
Not Applicable 2
Data Issue 2
Pressure issue 2
Temperature issue 1
Connection issue 1
Delamination 1
Buckled material 1
Failure to zero 1
Difficult to remove 1
Material rigid or stiff 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
Crack 1
Degraded 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
Material frayed 1
Image display error 1
Image resolution poor 1
Flaked 1
Fluid leak 1
Difficult to insert 1
Smoking 1
Sticking 1
Device inoperable 1
Mechanical issue 1
Misconnection 1
Total Device Problems 639

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

-
-