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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 12
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 17
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to form staple 1267
Replace 537
Difficult to open or close 276
Misfire 256
Mechanical jam 255
Sticking 238
Break 202
Device operates differently than expected 194
Failure to Adhere or Bond 192
Component falling 174
Malfunction 169
Unintended ejection 158
Deployment issue 115
Detachment of device component 107
Failure to fire 104
Difficult to remove 98
Failure to deploy 96
Device Issue 87
Other (for use when an appropriate device code cannot be identified) 72
Failure to advance 70
Failure to align 60
Slippage of device or device component 52
Device, removal of (non-implant) 48
Mechanical issue 47
Clips, scissored 43
Leak 40
Premature deployment 38
Device inoperable 36
Unknown (for use when the device problem is not known) 35
Dislodged or dislocated 34
No Known Device Problem 30
Device maintenance issue 27
Loose 25
Migration of device or device component 24
No code available 22
Entrapment of device or device component 20
Bent 19
Close, difficult to 16
Tear, rip or hole in device packaging 16
Tip breakage 14
No Information 13
Material deformation 12
Defective item 11
Device Difficult to Setup or Prepare 11
Fracture 11
Detachment of device or device component 10
Unintended movement 10
Loose or intermittent connection 9
Material fragmentation 8
Difficult to deploy 8
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
Component(s), broken 7
Material separation 7
Performance 6
Difficult to insert 6
Dislodged 6
Device packaging compromised 6
Expulsion 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
Mechanics altered 5
Malposition of device 5
Retraction problem 5
Tears, rips, holes in device, device material 4
Unsealed device packaging 4
Component missing 4
Use of Device Issue 4
Noise 3
Delivery system failure 3
Difficult to advance 3
Positioning Issue 3
Foreign material present in device 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
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 5626

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 4
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 LeMaitre Vascular, Inc. II Jul-25-2016
4 Medtronic Cardiac Surgery Technologies II Sep-16-2008
5 Medtronic Cardiac Surgery Technologies II Jun-27-2007
6 Medtronic Cardiovascular Revascularization & Surgical Therap II Jul-17-2010
7 Telefelx Medical II Sep-16-2008
8 Teleflex Medical II Aug-03-2016
9 Teleflex Medical II Feb-25-2016
10 Teleflex Medical II Dec-17-2014
11 Teleflex Medical II Oct-18-2012

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