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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, rigid
Regulation Description Rigid laryngoscope.
Product CodeCCW
Regulation Number 868.5540
Device Class 1


Premarket Reviews
ManufacturerDecision
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 5
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICHIGAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 1
TRUPHATEK INTERNATIONAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 107
Break 99
Erratic display 91
Optical issue 90
Device damaged prior to use 64
Material fragmentation 41
Failure to conduct 31
Detachment of device component 30
Fitting problem 29
Device operates differently than expected 29
Packaging issue 21
Detachment of device or device component 15
Device stops intermittently 15
Fracture 14
Overheating of device or device component 14
Difficult to position 11
Difficult to remove 11
Inadequate lighting 9
Failure to separate 9
Deployment issue 8
Material frayed 8
Connection issue 8
Light interference 6
Material separation 6
Out-of-box failure 5
Mechanical issue 5
Loss of or failure to bond 5
Component missing 4
No Known Device Problem 4
Difficult to deploy 4
Improper or incorrect procedure or method 4
Temperature issue 4
Mechanical jam 4
Poor quality image 3
Difficult to insert 3
Loose or intermittent connection 3
Material integrity issue 3
Bent 3
Power source issue 2
Battery issue 2
Electrical issue 2
Device Difficult to Setup or Prepare 2
No code available 2
No Information 2
Other (for use when an appropriate device code cannot be identified) 2
Device handling issue 2
Material Protrusion 2
Leak 1
Unintended movement 1
Defective item 1
Component(s), broken 1
Crack 1
Burn of device or device component 1
Device markings issue 1
Positioning Issue 1
Maintenance does not comply to manufacturers recommendations 1
Dislodged or dislocated 1
Smoking 1
Use of Device Issue 1
Structural problem 1
Degraded 1
Heat 1
Failure, intermittent 1
Invalid sensing 1
Improper device output 1
Defective component 1
Device inoperable 1
Corrosion 1
Image resolution poor 1
Misconnection 1
Total Device Problems 861

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 0 0 0 1 1 0 0 1
Class II 1 0 0 0 2 1 1 3 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aircraft Medical Limited II Dec-02-2014
2 Penlon, Ltd. II Mar-18-2012
3 Penlon, Ltd. (Fmly East Healthcare) II Sep-14-2011
4 Sun Med, Inc. I Dec-24-2008
5 Teleflex Medical II Jul-29-2014
6 Teleflex Medical II Jul-26-2014
7 Teleflex Medical II Nov-20-2013
8 Teleflex Medical II May-02-2007
9 Verathon, Inc. I Mar-11-2016
10 Verathon, Inc. II Dec-15-2015
11 Verathon, Inc. II Jul-13-2015
12 Verathon, Inc. I Jun-20-2013
13 Verathon, Inc. I Dec-07-2012
14 Vital Signs Colorado Inc. II Feb-02-2011

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