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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 8
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDICA, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 1290
Replace 443
Failure to fire 413
Device operates differently than expected 295
Break 256
Difficult to open or close 217
Sticking 214
Misfire 173
Failure to cut 161
Failure to deploy 149
Difficult to remove 124
Device Issue 122
Mechanical jam 118
Use of Device Issue 116
Unknown (for use when the device problem is not known) 112
Failure to cycle 99
No Known Device Problem 97
Detachment of device component 94
Mechanical issue 91
Other (for use when an appropriate device code cannot be identified) 81
No Information 77
Device, removal of (non-implant) 74
Failure to Adhere or Bond 69
Component falling 63
Device inoperable 56
Device stops intermittently 56
Entrapment of device or device component 51
Leak 51
Retraction problem 42
Noise, Audible 27
Failure to advance 25
Difficult or delayed activation 23
Unintended arm motion 21
Malfunction 17
No code available 17
Detachment of device or device component 16
Physical resistance 16
Noise 16
Slippage of device or device component 15
Bent 15
Dislodged or dislocated 15
Improper or incorrect procedure or method 14
Component missing 14
Air leak 13
Crack 13
Material deformation 13
Deployment issue 12
Loose 12
System fails to activate 12
Device displays error message 11
Device packaging compromised 10
Human-Device Interface Issue 10
Device maintenance issue 10
Difficult to deploy 10
Component(s), broken 9
Unintended ejection 9
Material separation 9
Close, difficult to 9
Defective item 9
Device Difficult to Setup or Prepare 8
Tear, rip or hole in device packaging 8
Loose or intermittent connection 8
Blockage within device or device component 8
Unsealed device packaging 7
Failure to deliver 7
Failure to separate 7
Packaging issue 7
Difficult to advance 6
Failure to align 6
Device damaged prior to use 6
Defective component 6
Fitting problem 6
Self-activation or keying 6
Migration of device or device component 6
Difficult to insert 6
Calibration error 6
Fluid leak 5
Loss of power 5
Malposition of device 5
Torn material 5
Unintended movement 4
Connection issue 4
Foreign material present in device 4
Hole in material 4
Disconnection 4
Failure to discharge 3
Application interface becomes non-functional or program exits abnormally 3
Loss of or failure to bond 3
Material fragmentation 3
Unintended head motion 3
Unintended system motion 3
Method, improper/incorrect 3
Difficult to position 3
Material rupture 3
Suture line disruption 3
Suture line separation 3
Material perforation 3
Source, leak(s) from 3
Failure to disconnect 3
Cut in material 3
Total Device Problems 5825

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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