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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 1268
Replace 537
Difficult to open or close 351
Mechanical jam 282
Misfire 268
Sticking 238
Break 211
Failure to Adhere or Bond 205
Device operates differently than expected 195
Component falling 174
Malfunction 169
Deployment issue 169
Unintended ejection 162
Detachment of device component 110
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
Failure to align 60
Slippage of device or device component 59
Mechanical issue 53
Premature deployment 52
Device, removal of (non-implant) 48
Clips, scissored 43
Leak 40
No Known Device Problem 37
Device inoperable 36
Unknown (for use when the device problem is not known) 35
Dislodged or dislocated 34
Migration of device or device component 29
Device maintenance issue 27
Unintended movement 25
Loose 25
Entrapment of device or device component 25
No code available 23
Bent 20
Tear, rip or hole in device packaging 17
Close, difficult to 16
No Information 15
Material deformation 14
Tip breakage 14
Difficult to deploy 13
Device Difficult to Setup or Prepare 11
Fracture 11
Defective item 11
Detachment of device or device component 11
Failure to separate 10
Material fragmentation 9
Loose or intermittent connection 9
Failure to disconnect 8
Device or device fragments location unknown 8
Material twisted 8
Physical resistance 7
Defective component 7
Failure to deliver 7
Component(s), broken 7
Material separation 7
Out-of-box failure 6
Device packaging compromised 6
Expulsion 6
Dent in material 6
Dislodged 6
Implant, removal of 6
Difficult to insert 6
Performance 6
Retraction problem 5
Excessive Manipulation 5
Mechanics altered 5
Difficult or delayed activation 5
Malposition of device 5
Unsealed device packaging 5
Foreign material present in device 4
Positioning Issue 4
Noise, Audible 4
Component missing 4
Use of Device Issue 4
Tears, rips, holes in device, device material 4
Noise 3
Improper or incorrect procedure or method 3
Self-activation or keying 3
Difficult to position 3
Delivery system failure 3
Difficult to advance 3
Blockage within device or device component 3
Hole in material 3
Material Protrusion 2
Fitting problem 2
Disconnection 2
Material perforation 2
Crack 2
Fluid leak 2
Fail-safe mechanism issue 2
Twisting 2
Material puncture 2
Metal shedding debris 2
Material integrity issue 2
Device, or device fragments remain in patient 2
Patient-device incompatibility 2
Total Device Problems 5914

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

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