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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 15
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 13
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 17
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to form staple 1380
Misfire 709
Replace 537
Mechanical jam 491
Failure to Adhere or Bond 449
Difficult to open or close 357
Sticking 238
Unintended ejection 236
Break 214
Device operates differently than expected 197
Deployment issue 174
Component falling 174
Malfunction 169
Detachment of device component 111
Failure to fire 105
Difficult to remove 100
Failure to deploy 98
Device Issue 87
Other (for use when an appropriate device code cannot be identified) 72
Failure to advance 70
Slippage of device or device component 63
Failure to align 61
Mechanical issue 57
Premature deployment 55
Device, removal of (non-implant) 48
Clips, scissored 43
No Known Device Problem 42
Leak 40
Device inoperable 36
Unknown (for use when the device problem is not known) 35
Dislodged or dislocated 35
Migration of device or device component 28
Unintended movement 28
Device maintenance issue 27
Loose 25
Entrapment of device or device component 24
No code available 23
Bent 20
Tear, rip or hole in device packaging 17
Physical resistance 17
Material deformation 16
Close, difficult to 16
No Information 15
Tip breakage 14
Difficult to deploy 13
Failure to separate 12
Use of Device Issue 11
Defective item 11
Detachment of device or device component 11
Fracture 11
Device Difficult to Setup or Prepare 11
Material fragmentation 10
Loose or intermittent connection 9
Device or device fragments location unknown 8
Material twisted 8
Failure to disconnect 8
Failure to deliver 7
Defective component 7
Material separation 7
Difficult to insert 7
Component(s), broken 7
Dislodged 6
Performance 6
Out-of-box failure 6
Implant, removal of 6
Dent in material 6
Expulsion 6
Device packaging compromised 6
Malposition of device 5
Foreign material present in device 5
Excessive Manipulation 5
Difficult or delayed activation 5
Unsealed device packaging 5
Retraction problem 5
Mechanics altered 5
Positioning Issue 4
Noise, Audible 4
Tears, rips, holes in device, device material 4
Difficult to position 4
Component missing 4
Improper or incorrect procedure or method 3
Noise 3
Delivery system failure 3
Difficult to advance 3
Patient-device incompatibility 3
Self-activation or keying 3
Hole in material 3
Blockage within device or device component 3
Crack 2
Failure to cycle 2
Disconnection 2
Fluid leak 2
Material puncture 2
Device, or device fragments remain in patient 2
Chemical issue 2
Component or accessory incompatibility 2
Folded 2
Fail-safe mechanism issue 2
Material integrity issue 2
Fitting problem 2
Total Device Problems 7056

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 1 2 0 1 0 1 1 1 0 5 1
Class III 0 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 AtriCure, Inc. II Feb-08-2017
3 AtriCure, Inc. II Nov-09-2016
4 Bard Peripheral Vascular Inc II Jun-08-2013
5 LeMaitre Vascular, Inc. II Jul-25-2016
6 Medtronic Cardiac Surgery Technologies II Sep-16-2008
7 Medtronic Cardiac Surgery Technologies II Jun-27-2007
8 Medtronic Cardiovascular Revascularization & Surgical Therap II Jul-17-2010
9 Telefelx Medical II Sep-16-2008
10 Teleflex Medical II Aug-03-2016
11 Teleflex Medical II Feb-25-2016
12 Teleflex Medical II Dec-17-2014
13 Teleflex Medical II Oct-18-2012

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