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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 91
Tip breakage 22
Material fragmentation 21
Device, or device fragments remain in patient 20
Unknown (for use when the device problem is not known) 16
No Known Device Problem 7
Device Issue 7
Device operates differently than expected 6
Foreign material 5
Detachment of device component 5
Metal shedding debris 4
Retraction problem 3
Difficult to remove 3
Detachment of device or device component 3
Component falling 2
Foreign material present in device 2
Sticking 2
Material integrity issue 2
Misfire 2
Improper or incorrect procedure or method 1
Device inoperable 1
Device contamination with blood or blood product 1
Failure to Adhere or Bond 1
Product quality issue 1
Fracture 1
Bent 1
Fail-safe design failure 1
Material deformation 1
Membrane leak(s) 1
Item contaminated during manufacturing or shipping 1
Shock, electrical 1
Size incorrect for patient 1
Unintended collision 1
Material separation 1
Manufacturing or shipping issue associated with device 1
Dull 1
Premature system activation 1
Cut in material 1
Mechanical issue 1
Crack 1
Device or device fragments location unknown 1
Total Device Problems 245

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 2 2 0 1 3 0 1 5 0
Class III 1 0 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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