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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 1267
Replace 537
Difficult to open or close 287
Misfire 258
Mechanical jam 256
Sticking 238
Break 204
Failure to Adhere or Bond 195
Device operates differently than expected 194
Component falling 174
Malfunction 169
Unintended ejection 158
Deployment issue 118
Detachment of device component 108
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 55
Mechanical issue 50
Device, removal of (non-implant) 48
Premature deployment 44
Clips, scissored 43
Leak 40
Device inoperable 36
Unknown (for use when the device problem is not known) 35
Dislodged or dislocated 34
No Known Device Problem 31
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
Tear, rip or hole in device packaging 17
Close, difficult to 16
Tip breakage 14
No Information 13
Material deformation 12
Defective item 11
Device Difficult to Setup or Prepare 11
Difficult to deploy 11
Fracture 11
Detachment of device or device component 10
Unintended movement 10
Loose or intermittent connection 9
Material fragmentation 8
Material twisted 8
Device or device fragments location unknown 8
Failure to disconnect 8
Failure to separate 8
Failure to deliver 7
Defective component 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
Out-of-box failure 6
Implant, removal of 6
Dent in material 6
Excessive Manipulation 5
Difficult or delayed activation 5
Malposition of device 5
Unsealed device packaging 5
Retraction problem 5
Mechanics altered 5
Tears, rips, holes in device, device material 4
Positioning Issue 4
Component missing 4
Use of Device Issue 4
Noise 3
Difficult to advance 3
Foreign material present in device 3
Delivery system failure 3
Self-activation or keying 3
Difficult to position 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
Patient-device incompatibility 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
Total Device Problems 5670

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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