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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscopic accessories, gynecologic
Regulation Description Gynecologic laparoscope and accessories.
Definition Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Product CodeNWV
Regulation Number 884.1720
Device Class 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 13
Detachment of device component 9
No Known Device Problem 5
Material separation 4
Break 2
Mechanical issue 2
Entrapment of device or device component 1
Defective item 1
Device operates differently than expected 1
Difficult to advance 1
Total Device Problems 39

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

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Jun-07-2013
2 JosNoe Medical, Inc. II Jan-30-2016

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