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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories,arthroscopic
Regulation Description Arthroscope.
Product CodeNBH
Regulation Number 888.1100
Device Class 1


Premarket Reviews
ManufacturerDecision
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 89
Tip breakage 22
Material fragmentation 20
Device, or device fragments remain in patient 20
Unknown (for use when the device problem is not known) 16
Device Issue 7
No Known Device Problem 6
Detachment of device component 5
Foreign material 5
Metal shedding debris 4
Detachment of device or device component 3
Difficult to remove 3
Component falling 2
Device operates differently than expected 2
Misfire 2
Device or device fragments location unknown 1
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Improper or incorrect procedure or method 1
Device inoperable 1
Cut in material 1
Device contamination with blood or blood product 1
Crack 1
Shock, electrical 1
Fracture 1
Failure to Adhere or Bond 1
Bent 1
Material separation 1
Size incorrect for patient 1
Sticking 1
Mechanical issue 1
Membrane leak(s) 1
Unintended collision 1
Premature system activation 1
Product quality issue 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 2 2 0 1 3 0 1 5
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ceterix Orthopedics, Inc. II Nov-09-2015
2 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-09-2013
3 Instratek, Incorporated II Mar-08-2013
4 Integra LifeSciences Corp. II Mar-19-2012
5 Smith & Nephew, Inc Endoscopy Division III Jun-06-2007
6 Smith & Nephew, Inc. II Jul-18-2016
7 Smith & Nephew, Inc. II Feb-10-2016
8 Smith & Nephew, Inc. Endoscopy Division II Oct-12-2010
9 Smith & Nephew, Inc. Endoscopy Division II Jul-14-2009
10 Smith & Nephew, Inc., Endoscopy Div. II Feb-18-2016
11 Smith & Nephew, Inc., Endoscopy Div. II Jan-29-2016
12 Smith & Nephew, Inc., Endoscopy Div. II Nov-24-2009
13 Stryker Corporation II Jun-03-2016
14 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
15 TAG Medical Corp. II Jan-19-2010

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