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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device holder, needle, gastroenterologic
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeFHQ
Regulation Number 876.4730
Device Class 1

Device Problems
Detachment of device component 78
Retraction problem 32
Break 23
Needle, separation 20
Unknown (for use when the device problem is not known) 10
No Known Device Problem 9
Other (for use when an appropriate device code cannot be identified) 7
Tip breakage 5
Device, or device fragments remain in patient 4
Device or device fragments location unknown 4
No code available 3
Fracture 3
Mechanical issue 2
Difficult to remove 2
Bent 2
No Information 2
Device packaging compromised 2
Foreign material present in device 2
Packaging issue 1
Device handling issue 1
Difficult to deploy 1
Dislodged 1
Device inoperable 1
Improper or incorrect procedure or method 1
Tear, rip or hole in device packaging 1
Malfunction 1
Expiration date error 1
Misfire 1
Total Device Problems 220

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

Recalls
Manufacturer Recall Class Date Posted
1 Davol, Inc., Sub. C. R. Bard, Inc. II Sep-06-2009

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