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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 611
Break 193
Optical issue 170
Erratic display 158
Device damaged prior to use 128
Material fragmentation 46
Fitting problem 42
Device operates differently than expected 36
Failure to conduct 31
Detachment of device component 30
Detachment of device or device component 22
Packaging issue 21
Device stops intermittently 15
Overheating of device or device component 14
Fracture 14
Inadequate lighting 14
Battery issue 12
Difficult to remove 12
Difficult to position 11
Material frayed 9
Connection issue 9
Failure to separate 9
Deployment issue 8
Power source issue 8
Crack 8
Material separation 8
Bent 6
Light interference 6
Out-of-box failure 5
Loss of or failure to bond 5
Loose or intermittent connection 5
Mechanical issue 5
Improper or incorrect procedure or method 4
Difficult to deploy 4
Temperature issue 4
Mechanical jam 4
No Known Device Problem 4
Component missing 4
Material integrity issue 3
Product quality issue 3
Poor quality image 3
Difficult to insert 3
Electrical issue 2
Device inoperable 2
Device Difficult to Setup or Prepare 2
Material Protrusion 2
No Information 2
No code available 2
Device handling issue 2
Other (for use when an appropriate device code cannot be identified) 2
Device markings issue 2
Maintenance does not comply to manufacturers recommendations 1
Dislodged or dislocated 1
Improper device output 1
Defective component 1
Invalid sensing 1
Structural problem 1
Defective item 1
Unintended movement 1
Positioning Issue 1
Smoking 1
Use of Device Issue 1
Failure, intermittent 1
Leak 1
Misconnection 1
Disconnection 1
Heat 1
Image resolution poor 1
Burn of device or device component 1
Component(s), broken 1
Degraded 1
Corrosion 1
Total Device Problems 1746

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 0 0 0 1 1 0 0 1 0
Class II 1 0 0 0 2 1 1 3 2 0 1
Class III 0 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 II Apr-18-2017
10 Verathon, Inc. I Mar-11-2016
11 Verathon, Inc. II Dec-15-2015
12 Verathon, Inc. II Jul-13-2015
13 Verathon, Inc. I Jun-20-2013
14 Verathon, Inc. I Dec-07-2012
15 Vital Signs Colorado Inc. II Feb-02-2011

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