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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 9
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 41
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 1503
Failure to fire 615
Replace 443
Misfire 346
Break 343
Device operates differently than expected 319
Difficult to open or close 276
Failure to cycle 275
Sticking 216
Failure to Adhere or Bond 199
No Known Device Problem 194
Failure to cut 180
Failure to deploy 173
Difficult to remove 168
Device Issue 123
Entrapment of device or device component 120
Mechanical jam 119
Detachment of device component 118
Use of Device Issue 116
Unknown (for use when the device problem is not known) 113
Mechanical issue 98
No Information 98
Device displays error message 97
Noise, Audible 90
Device stops intermittently 86
Other (for use when an appropriate device code cannot be identified) 81
Device, removal of (non-implant) 74
Component falling 66
Leak 60
Device inoperable 59
Retraction problem 50
Unintended arm motion 48
Detachment of device or device component 43
Human-Device Interface Issue 35
Fluid leak 35
Bent 34
Failure to advance 28
No code available 27
Difficult or delayed activation 26
Air leak 20
Material deformation 19
Physical resistance 17
Difficult to advance 17
Malfunction 17
Component missing 17
Noise 16
Difficult to deploy 16
Slippage of device or device component 15
Device Difficult to Setup or Prepare 15
Dislodged or dislocated 15
Deployment issue 14
Difficult to position 14
Improper or incorrect procedure or method 14
Crack 13
Unintended ejection 12
Loose 12
System fails to activate 12
Calibration error 11
Component or accessory incompatibility 11
Calibration issue 11
Device packaging compromised 10
Device maintenance issue 10
Failure to calibrate 10
Tear, rip or hole in device packaging 10
Material separation 9
Loose or intermittent connection 9
Component(s), broken 9
Failure to separate 9
Close, difficult to 9
Defective item 9
Failure to align 8
Expulsion 8
Power source issue 8
Packaging issue 8
Blockage within device or device component 8
Unintended system motion 8
Device damaged prior to use 8
Failure to deliver 7
Self-activation or keying 7
Failure to sense 7
Unsealed device packaging 7
Migration of device or device component 7
Bleed back 7
Malposition of device 7
Connection issue 6
Difficult to insert 6
Failure to read input signal 6
Defective component 6
Fitting problem 6
Material perforation 5
Loss of power 5
Unintended head motion 5
Device markings issue 5
Failure to disconnect 5
Torn material 5
Fail-safe mechanism issue 5
Foreign material present in device 5
Unintended movement 4
Device or device fragments location unknown 4
Communication or transmission issue 4
Total Device Problems 7683

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 1 0 0 1 0 0
Class II 4 0 1 2 3 5 2 1 5 2 0
Class III 0 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 Oct-20-2016
13 Ethicon Endo-Surgery Inc II May-21-2015
14 Ethicon Endo-Surgery Inc II Jun-11-2013
15 Ethicon Endo-Surgery Inc I Oct-13-2012
16 Ethicon Endo-Surgery Inc II May-18-2012
17 Ethicon Endo-Surgery Inc II Sep-12-2011
18 Ethicon Endo-Surgery Inc II Nov-15-2010
19 Ethicon Endo-Surgery Inc II Jun-28-2007
20 Ethicon, Inc. II Feb-18-2011
21 Incisive Surgical Inc II Apr-29-2015
22 Justright Surgical, LLC II Jul-02-2015
23 Justright Surgical, LLC II Sep-23-2014
24 Laax, Inc. I Apr-23-2015
25 Medtronic II Feb-18-2016
26 Power Medical Interventions, Inc II Jul-24-2007
27 Surgical Devices/Covidien II Nov-23-2009

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