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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, implantable
Regulation Description Implantable clip.
Product CodeFZP
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACKERMANN INSTRUMENTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ANSON MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 4
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 7
BYPASS
  SUBSTANTIALLY EQUIVALENT 1
CARDICA, INC.
  SUBSTANTIALLY EQUIVALENT 10
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
DESIGN STANDARDS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 14
GENICON
  SUBSTANTIALLY EQUIVALENT 2
GYRX, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICINELODGE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MILTEX
  SUBSTANTIALLY EQUIVALENT 1
NITI
  SUBSTANTIALLY EQUIVALENT 6
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
SANARUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 12
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 17
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to form staple 1263
Replace 537
Misfire 246
Difficult to open or close 246
Mechanical jam 246
Sticking 238
Break 196
Device operates differently than expected 192
Component falling 174
Malfunction 169
Failure to Adhere or Bond 168
Unintended ejection 155
Detachment of device component 103
Failure to fire 102
Deployment issue 101
Difficult to remove 98
Failure to deploy 93
Device Issue 87
Other (for use when an appropriate device code cannot be identified) 72
Failure to advance 70
Failure to align 60
Device, removal of (non-implant) 48
Clips, scissored 43
Slippage of device or device component 42
Leak 40
Device inoperable 36
Unknown (for use when the device problem is not known) 35
Dislodged or dislocated 34
Mechanical issue 34
Premature deployment 31
Device maintenance issue 27
Loose 25
No code available 22
Migration of device or device component 21
Bent 19
No Known Device Problem 19
Entrapment of device or device component 18
Close, difficult to 16
Tear, rip or hole in device packaging 16
Tip breakage 14
No Information 13
Device Difficult to Setup or Prepare 11
Defective item 11
Material deformation 11
Unintended movement 10
Detachment of device or device component 10
Fracture 10
Loose or intermittent connection 9
Material twisted 8
Device or device fragments location unknown 8
Failure to disconnect 8
Failure to separate 8
Failure to deliver 7
Physical resistance 7
Material separation 7
Component(s), broken 7
Difficult to deploy 7
Material fragmentation 6
Difficult to insert 6
Dislodged 6
Performance 6
Device packaging compromised 6
Dent in material 6
Implant, removal of 6
Defective component 6
Out-of-box failure 6
Excessive Manipulation 5
Difficult or delayed activation 5
Malposition of device 5
Mechanics altered 5
Retraction problem 5
Tears, rips, holes in device, device material 4
Unsealed device packaging 4
Component missing 4
Use of Device Issue 3
Noise 3
Positioning Issue 3
Difficult to advance 3
Foreign material present in device 3
Delivery system failure 3
Difficult to position 3
Self-activation or keying 3
Hole in material 3
Blockage within device or device component 3
Crack 2
Disconnection 2
Fluid leak 2
Material puncture 2
Device, or device fragments remain in patient 2
Expulsion 2
Fail-safe mechanism issue 2
Material integrity issue 2
Fitting problem 2
Metal shedding debris 2
Improper or incorrect procedure or method 2
Material perforation 2
Twisting 2
Noise, Audible 2
Fungus in device environment 1
Device damaged prior to use 1
Total Device Problems 5459

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 1 2 0 1 0 1 1 1 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II May-06-2016
2 Bard Peripheral Vascular Inc II Jun-08-2013
3 Medtronic Cardiac Surgery Technologies II Sep-16-2008
4 Medtronic Cardiac Surgery Technologies II Jun-27-2007
5 Medtronic Cardiovascular Revascularization & Surgical Therap II Jul-17-2010
6 Telefelx Medical II Sep-16-2008
7 Teleflex Medical II Feb-25-2016
8 Teleflex Medical II Dec-17-2014
9 Teleflex Medical II Oct-18-2012

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