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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bronchoscope (flexible or rigid)
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Product CodeEOQ
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
AOMORI OLYMPUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SE - WITH LIMITATIONS 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 2
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 12
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 19
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 12
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Retraction problem 74
No Known Device Problem 74
Bent 57
Break 49
Bacterial contamination of device 46
Device Cleaning Issue 38
Detachment of device component 30
Other (for use when an appropriate device code cannot be identified) 26
No Information 22
Vacuum, loss of 17
Difficult to remove 17
Kinked 17
No display or display failure 16
Material puncture 16
Device disinfection or sterilization issue 14
Leak 13
Loose or intermittent connection 12
Disinfection or Sterilization Issue at User Location 12
Detachment of device or device component 11
No code available 10
Suction issue 10
Failure to advance 9
Material fragmentation 8
Peeled 8
Contamination during use 7
Crack 6
Component(s), broken 6
Maintenance does not comply to manufacturers recommendations 6
Torn material 5
Needle, unsheathed 5
Device Issue 5
Material separation 5
Device inoperable 4
Fungus in device environment 4
Fracture 4
Flaked 4
Burn of device or device component 4
Mechanical jam 4
Foreign material present in device 4
Device operates differently than expected 3
Device or device component damaged by another device 3
Dislodged or dislocated 3
Device handling issue 3
Aspiration, incomplete 3
Wire(s), breakage of 3
Obstruction within device 3
Device or device fragments location unknown 3
Unknown (for use when the device problem is not known) 3
Device damaged prior to use 2
Use of Device Issue 2
Valve(s), failure of 2
Image resolution poor 2
Cut in material 2
Loss of or failure to bond 2
Failure to disinfect 2
Material disintegration 2
Dislodged 2
Difficult to fold or unfold 2
Flare or flash 2
Material deformation 2
Material Protrusion 1
Power source issue 1
Foreign material 1
Entrapment of device or device component 1
Device expiration issue 1
Fiberoptic break/separation 1
Unintended ejection 1
Fire 1
Charred 1
Image display error 1
Normal 1
Occlusion within device 1
Performance 1
Difficult to position 1
Loose 1
Mechanical issue 1
Misassembled 1
Misfocusing 1
Poor quality image 1
Needle, separation 1
Physical resistance 1
Defective item 1
Close, difficult to 1
Buckled material 1
Deployment issue 1
Dull 1
Malfunction 1
Solder joint failure 1
Fitting problem 1
Material rupture 1
Inappropriate shock 1
Source, detachment from 1
Sticking 1
Syringe, defective 1
Tears, rips, holes in device, device material 1
Improper or incorrect procedure or method 1
Defective component 1
Tube(s), defective 1
Total Device Problems 768

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 2 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ConMed Corporation II Dec-10-2012
2 Pentax Medical Company II Jan-20-2012

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