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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 10
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 42
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 fire 2564
Failure to form staple 2424
Misfire 920
Difficult to open or close 764
Break 554
No Known Device Problem 513
Entrapment of device or device component 487
Human-Device Interface Issue 447
Replace 443
Detachment of device component 375
Noise, Audible 371
Failure to Adhere or Bond 364
Device operates differently than expected 328
Failure to cycle 287
Difficult to remove 270
Device displays error message 237
Failure to cut 223
Sticking 218
Mechanics altered 191
Failure to deploy 181
Mechanical jam 140
Device Issue 123
Use of Device Issue 116
Unknown (for use when the device problem is not known) 113
Retraction problem 111
Device inoperable 109
Mechanical issue 106
No Information 102
Fluid leak 101
Device stops intermittently 86
Other (for use when an appropriate device code cannot be identified) 82
Bent 76
Device, removal of (non-implant) 74
Unintended movement 67
Component falling 66
Detachment of device or device component 64
Failure to sense 63
Leak 62
No code available 62
Device Difficult to Setup or Prepare 59
Difficult to deploy 58
Physical resistance 56
Unintended arm motion 48
Expulsion 47
Difficult or delayed activation 43
Positioning Issue 41
Failure to read input signal 40
Difficult to position 39
Air leak 39
Failure to advance 37
Slippage of device or device component 31
Fail-safe mechanism issue 28
Failure to align 27
Unintended system motion 25
Difficult to advance 24
Failure to separate 23
Component missing 23
Unintended head motion 22
Material deformation 22
Failure to calibrate 19
Calibration issue 18
Malfunction 17
Noise 16
Component or accessory incompatibility 16
Deployment issue 15
Dislodged or dislocated 15
Improper or incorrect procedure or method 14
Difficult to insert 13
Crack 13
Calibration error 12
Loose 12
Unintended ejection 12
System fails to activate 12
Material separation 12
Packaging issue 12
Tear, rip or hole in device packaging 11
Device maintenance issue 10
Extrusion 10
Device packaging compromised 10
Close, difficult to 9
Defective item 9
Power source issue 9
Migration of device or device component 9
Loose or intermittent connection 9
Component(s), broken 9
Blockage within device or device component 8
Device damaged prior to use 8
Unsealed device packaging 8
Device remains activated 8
Disinfection or Sterilization Issue at User Location 8
Malposition of device 7
Self-activation or keying 7
Failure to deliver 7
Bleed back 7
Failure to charge 6
Defective component 6
Fitting problem 6
Connection issue 6
Torn material 6
Foreign material present in device 6
Total Device Problems 15043

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 1
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 May-31-2017
13 Ethicon Endo-Surgery Inc II Oct-20-2016
14 Ethicon Endo-Surgery Inc II May-21-2015
15 Ethicon Endo-Surgery Inc II Jun-11-2013
16 Ethicon Endo-Surgery Inc I Oct-13-2012
17 Ethicon Endo-Surgery Inc II May-18-2012
18 Ethicon Endo-Surgery Inc II Sep-12-2011
19 Ethicon Endo-Surgery Inc II Nov-15-2010
20 Ethicon Endo-Surgery Inc II Jun-28-2007
21 Ethicon, Inc. II Feb-18-2011
22 Incisive Surgical Inc II Apr-29-2015
23 Justright Surgical, LLC II Jul-02-2015
24 Justright Surgical, LLC II Sep-23-2014
25 Laax, Inc. I Apr-23-2015
26 Medtronic II Feb-18-2016
27 Power Medical Interventions, Inc II Jul-24-2007
28 Surgical Devices/Covidien II Nov-23-2009

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