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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 689
Break 202
Optical issue 185
Erratic display 162
Device damaged prior to use 135
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 23
Packaging issue 21
Overheating of device or device component 16
Device stops intermittently 15
Battery issue 14
Inadequate lighting 14
Fracture 14
Difficult to remove 12
Difficult to position 11
Material separation 9
Loose or intermittent connection 9
Material frayed 9
Connection issue 9
Failure to separate 9
Deployment issue 8
Power source issue 8
Crack 8
Bent 6
Temperature issue 6
Light interference 6
No Known Device Problem 6
Out-of-box failure 5
Loss of or failure to bond 5
Mechanical issue 5
Difficult to deploy 4
Improper or incorrect procedure or method 4
Component missing 4
Mechanical jam 4
Material integrity issue 3
Poor quality image 3
Difficult to insert 3
Product quality issue 3
Device Difficult to Setup or Prepare 2
Electrical issue 2
Material Protrusion 2
Device markings issue 2
Improper device output 2
No Information 2
No code available 2
Device handling issue 2
Device inoperable 2
Other (for use when an appropriate device code cannot be identified) 2
Defective component 1
Invalid sensing 1
Use of Device Issue 1
Metal shedding debris 1
Structural problem 1
Defective item 1
Unintended movement 1
Positioning Issue 1
Dislodged or dislocated 1
Maintenance does not comply to manufacturers recommendations 1
Failure, intermittent 1
Leak 1
No device output 1
Misconnection 1
Smoking 1
Material rupture 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 1877

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 2
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 Bomimed II Sep-29-2017
3 Penlon, Ltd. II Mar-18-2012
4 Penlon, Ltd. (Fmly East Healthcare) II Sep-14-2011
5 Sun Med, Inc. I Dec-24-2008
6 Teleflex Medical II Jul-29-2014
7 Teleflex Medical II Jul-26-2014
8 Teleflex Medical II Nov-20-2013
9 Teleflex Medical II May-02-2007
10 Verathon Inc II Apr-18-2017
11 Verathon, Inc. I Mar-11-2016
12 Verathon, Inc. II Dec-15-2015
13 Verathon, Inc. II Jul-13-2015
14 Verathon, Inc. I Jun-20-2013
15 Verathon, Inc. I Dec-07-2012
16 Vital Signs Colorado Inc. II Feb-02-2011

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