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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 93
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
Device Issue 7
No Known Device Problem 7
Device operates differently than expected 6
Detachment of device component 5
Foreign material 5
Metal shedding debris 4
Difficult to remove 3
Retraction problem 3
Detachment of device or device component 3
Material integrity issue 2
Fracture 2
Component falling 2
Device inoperable 2
Use of Device Issue 2
Misfire 2
Foreign material present in device 2
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Device or device fragments location unknown 1
Difficult to open or close 1
Improper or incorrect procedure or method 1
Dull 1
Cut in material 1
Device contamination with blood or blood product 1
Crack 1
Shock, electrical 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
Mechanical jam 1
Torn material 1
Total Device Problems 252

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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