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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic grasping/cutting instrument, non-powered
Regulation Description Endoscope and accessories.
Definition To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Product CodeOCZ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 79
Crack 41
Device packaging compromised 38
Break 26
Peeled 11
Material integrity issue 10
Mechanics altered 6
Device inoperable 3
Component missing 2
Device or device fragments location unknown 1
Device, removal of (non-implant) 1
Detachment of device or device component 1
Detachment of device component 1
Material discolored 1
Mechanical issue 1
Use of Device Issue 1
Difficult to open or close 1
Naturally worn 1
Misassembled by Users 1
Not Applicable 1
Total Device Problems 227

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

Recalls
Manufacturer Recall Class Date Posted
1 US Endoscopy Group Inc II Apr-16-2015

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