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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 341
Break 125
Erratic display 114
Optical issue 114
Device damaged prior to use 88
Material fragmentation 42
Fitting problem 40
Failure to conduct 31
Detachment of device component 30
Device operates differently than expected 30
Packaging issue 21
Detachment of device or device component 19
Device stops intermittently 15
Overheating of device or device component 14
Fracture 14
Inadequate lighting 13
Difficult to position 11
Difficult to remove 11
Failure to separate 9
Connection issue 8
Deployment issue 8
Material frayed 8
Material separation 6
Light interference 6
Out-of-box failure 5
Mechanical issue 5
Loss of or failure to bond 5
Difficult to deploy 4
Improper or incorrect procedure or method 4
Component missing 4
Mechanical jam 4
No Known Device Problem 4
Temperature issue 4
Material integrity issue 3
Bent 3
Loose or intermittent connection 3
Poor quality image 3
Difficult to insert 3
Device Difficult to Setup or Prepare 2
Device inoperable 2
Other (for use when an appropriate device code cannot be identified) 2
Electrical issue 2
Material Protrusion 2
Battery issue 2
Power source issue 2
No Information 2
No code available 2
Device handling issue 2
Unintended movement 1
Positioning Issue 1
Defective component 1
Invalid sensing 1
Structural problem 1
Defective item 1
Maintenance does not comply to manufacturers recommendations 1
Dislodged or dislocated 1
Improper device output 1
Device markings issue 1
Failure, intermittent 1
Heat 1
Image resolution poor 1
Burn of device or device component 1
Component(s), broken 1
Corrosion 1
Crack 1
Degraded 1
Use of Device Issue 1
Smoking 1
Leak 1
Misconnection 1
Total Device Problems 1214

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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