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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device battery, replacement, rechargeable
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeMOQ
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to charge 83
Device inoperable 72
Device operates differently than expected 35
Charging issue 34
Break 17
Failure to power-up 15
Battery issue 13
Crack 11
Device displays error message 10
Defective item 6
Loss of power 5
Noise, Audible 5
No display or display failure 4
Loose or intermittent connection 4
Overheating of device or device component 4
Mechanical issue 3
Component falling 3
Bent 3
Device stops intermittently 3
Smoking 3
Mechanical jam 3
Power source issue 2
Temperature issue 2
Torn material 2
Connection issue 2
Flare or flash 2
Device emits odor 2
Defective component 2
Component missing 2
Premature discharge of battery 2
Corrosion 2
Detachment of device component 2
Power Conditioning Issue 2
Failure to deliver energy 2
Fracture 1
Leak 1
Moisture damage 1
Circuit Failure 1
Failure to advance 1
Dent in material 1
Low battery 1
Slippage of device or device component 1
Sticking 1
Computer operating system issue 1
Material deformation 1
Detachment of device or device component 1
Failure of device to self-test 1
Total Device Problems 375

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 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Mar-11-2016

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