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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, implantable
Regulation Description Implantable staple.
Product CodeGDW
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 22
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 9
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
CARDIO THORACIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 8
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 40
INCISIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INRAD
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MARINA MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NITI
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
REACH SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 28
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to form staple 1311
Failure to fire 444
Replace 443
Device operates differently than expected 301
Break 277
Difficult to open or close 221
Sticking 214
Misfire 181
Failure to cut 165
Failure to cycle 159
Failure to deploy 152
Difficult to remove 136
Device Issue 122
Mechanical jam 118
Use of Device Issue 116
Unknown (for use when the device problem is not known) 112
Failure to Adhere or Bond 106
No Known Device Problem 106
Detachment of device component 98
Mechanical issue 92
Other (for use when an appropriate device code cannot be identified) 81
No Information 78
Device, removal of (non-implant) 74
Entrapment of device or device component 68
Component falling 63
Device stops intermittently 63
Device inoperable 56
Leak 52
Retraction problem 42
Noise, Audible 35
Unintended arm motion 34
Failure to advance 25
Difficult or delayed activation 23
Detachment of device or device component 22
Device displays error message 21
Bent 20
No code available 19
Malfunction 17
Noise 16
Physical resistance 16
Dislodged or dislocated 15
Slippage of device or device component 15
Air leak 15
Improper or incorrect procedure or method 14
Component missing 14
Crack 13
Human-Device Interface Issue 13
Material deformation 13
Deployment issue 12
Difficult to deploy 12
Loose 12
System fails to activate 12
Calibration error 11
Device maintenance issue 10
Fluid leak 10
Device Difficult to Setup or Prepare 10
Device packaging compromised 10
Close, difficult to 9
Defective item 9
Material separation 9
Unintended ejection 9
Component(s), broken 9
Blockage within device or device component 8
Loose or intermittent connection 8
Tear, rip or hole in device packaging 8
Failure to align 7
Failure to separate 7
Failure to deliver 7
Device damaged prior to use 7
Unsealed device packaging 7
Difficult to advance 7
Packaging issue 7
Migration of device or device component 6
Difficult to insert 6
Defective component 6
Fitting problem 6
Self-activation or keying 6
Loss of power 5
Torn material 5
Malposition of device 5
Component or accessory incompatibility 5
Calibration issue 4
Device or device fragments location unknown 4
Connection issue 4
Foreign material present in device 4
Expulsion 4
Unintended movement 4
Hole in material 4
Material fragmentation 4
Disconnection 4
Difficult to position 4
Method, improper/incorrect 3
Material rupture 3
Suture line disruption 3
Suture line separation 3
Source, leak(s) from 3
Material perforation 3
Failure to disconnect 3
Excessive Manipulation 3
Cut in material 3
Total Device Problems 6145

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 1 0
Class II 4 0 1 2 3 5 2 1 5 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardica, Inc. II Dec-24-2015
2 Covidien LP II Apr-05-2013
3 Covidien LP II Sep-21-2012
4 Covidien LP II Jun-21-2012
5 Covidien LP II Mar-19-2012
6 Covidien LP II Feb-13-2012
7 Covidien LP II Sep-08-2011
8 Covidien LP II Mar-16-2010
9 Davol, Inc., Sub. C. R. Bard, Inc. II Sep-27-2007
10 Davol, Inc., Sub. C. R. Bard, Inc. II Feb-01-2007
11 EXP Pharmaceutical Services Corp II Jul-24-2015
12 Ethicon Endo-Surgery Inc II May-21-2015
13 Ethicon Endo-Surgery Inc II Jun-11-2013
14 Ethicon Endo-Surgery Inc I Oct-13-2012
15 Ethicon Endo-Surgery Inc II May-18-2012
16 Ethicon Endo-Surgery Inc II Sep-12-2011
17 Ethicon Endo-Surgery Inc II Nov-15-2010
18 Ethicon Endo-Surgery Inc II Jun-28-2007
19 Ethicon, Inc. II Feb-18-2011
20 Incisive Surgical Inc II Apr-29-2015
21 Justright Surgical, LLC II Jul-02-2015
22 Justright Surgical, LLC II Sep-23-2014
23 Laax, Inc. I Apr-23-2015
24 Medtronic II Feb-18-2016
25 Power Medical Interventions, Inc II Jul-24-2007
26 Surgical Devices/Covidien II Nov-23-2009

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