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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 For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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
Bacterial contamination of device 237
No display or display failure 207
No Known Device Problem 104
Device Cleaning Issue 90
No Information 18
Foreign material present in device 15
Break 14
Disinfection or Sterilization Issue at User Location 11
Material rigid or stiff 11
Obstruction within device 7
Excess flow or overinfusion 7
Mechanical issue 6
Poor quality image 6
Degraded 6
Material deformation 6
Device Issue 6
Detachment of device or device component 5
Increase in pressure 5
Use of Device Issue 4
Dent in material 4
Electro-static discharge 4
Device operates differently than expected 4
Detachment of device component 4
Contamination during use 4
Maintenance does not comply to manufacturers recommendations 4
Scratched material 3
Device handling issue 3
Leak 3
Electrical 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
Improper flow or infusion 2
Unknown (for use when the device problem is not known) 2
Material perforation 2
Spark 2
Material separation 2
Fire 2
Failure to flush 2
Loss of power 2
Corrosion 2
Blockage within device or device component 2
Device clogged 2
Incorrect display 2
Erratic display 2
Data Issue 2
Pressure issue 2
Not Applicable 2
No code available 1
Temperature issue 1
No Pressure 1
Positioning Issue 1
Power source issue 1
Bent 1
EKG/ECG analysis, failure to perform 1
Disconnection 1
Loss of or failure to bond 1
Charred 1
Crack 1
Occlusion within device 1
Misconnection 1
Difficult to insert 1
Material frayed 1
Image display error 1
Image resolution poor 1
Flaked 1
Fluid leak 1
Entrapment of device or device component 1
Smoking 1
Sticking 1
Device inoperable 1
Failure to zero 1
Difficult to remove 1
Buckled material 1
Device Rinsing Issue 1
Device contamination with blood or blood product 1
Solder joint failure 1
Connection issue 1
Delamination 1
Failure to shut off 1
Mechanical jam 1
Total Device Problems 881

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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