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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 62
Retraction problem 26
Needle, separation 20
Break 19
Unknown (for use when the device problem is not known) 10
Other (for use when an appropriate device code cannot be identified) 7
Tip breakage 5
Device or device fragments location unknown 4
Device, or device fragments remain in patient 4
Fracture 3
No code available 3
No Information 2
Mechanical issue 2
Difficult to remove 2
Bent 2
Device packaging compromised 2
No Known Device Problem 1
Packaging issue 1
Tear, rip or hole in device packaging 1
Malfunction 1
Expiration date error 1
Misfire 1
Difficult to deploy 1
Dislodged 1
Device inoperable 1
Device handling issue 1
Total Device Problems 183

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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