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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, surgical and accessories
Regulation Description Surgical camera and accessories.
Product CodeKQM
Regulation Number 878.4160
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDLINE
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 5
Detachment of device component 2
No Known Device Problem 2
Failure to Adhere or Bond 1
Break 1
Electrical issue 1
Fracture 1
Loss of threshold 1
Device inoperable 1
Device or device fragments location unknown 1
Total Device Problems 16

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 1 0 0 3 0 1 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Barco Inc. II Nov-05-2015
2 Conmed Linvatec Endoscopy Division II Sep-21-2008
3 Linvatec Corp. dba ConMed Linvatec II May-20-2013
4 Linvatec Corp. dba ConMed Linvatec II Apr-05-2011
5 Linvatec Corp. dba ConMed Linvatec II Jan-04-2011
6 Mako Surgical Corporation II May-20-2011
7 Sony Latin America II Apr-23-2015

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