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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ear, nose, and throat stereotaxic instrument
Regulation Description Stereotaxic instrument.
Definition Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Product CodePGW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Imprecision 20
Device operates differently than expected 17
Communication or transmission issue 13
Device stops intermittently 13
Application interface becomes non-functional or program exits abnormally 10
Computer software issue 4
Material deformation 4
Device displays error message 3
Bent 2
Suction issue 1
No display or display failure 1
Incorrect display 1
Electrical issue 1
Fracture 1
No Known Device Problem 1
Total Device Problems 92

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Apr-19-2017

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