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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 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 1475
Failure to fire 597
Replace 443
Break 336
Misfire 322
Device operates differently than expected 318
Difficult to open or close 271
Failure to cycle 267
Sticking 216
Failure to Adhere or Bond 187
Failure to cut 179
No Known Device Problem 179
Failure to deploy 173
Difficult to remove 167
Device Issue 123
Mechanical jam 119
Detachment of device component 117
Use of Device Issue 116
Unknown (for use when the device problem is not known) 113
Entrapment of device or device component 112
Mechanical issue 97
No Information 93
Device displays error message 93
Device stops intermittently 84
Other (for use when an appropriate device code cannot be identified) 81
Noise, Audible 79
Device, removal of (non-implant) 74
Component falling 65
Leak 60
Device inoperable 59
Retraction problem 50
Unintended arm motion 47
Detachment of device or device component 41
Human-Device Interface Issue 33
Bent 33
Fluid leak 32
Failure to advance 28
No code available 27
Difficult or delayed activation 26
Air leak 20
Material deformation 19
Malfunction 17
Component missing 17
Noise 16
Difficult to deploy 16
Difficult to advance 16
Physical resistance 16
Dislodged or dislocated 15
Slippage of device or device component 15
Device Difficult to Setup or Prepare 14
Improper or incorrect procedure or method 14
Difficult to position 13
Crack 13
Deployment issue 13
Unintended ejection 12
Loose 12
System fails to activate 12
Calibration error 11
Device maintenance issue 10
Failure to calibrate 10
Device packaging compromised 10
Calibration issue 10
Component or accessory incompatibility 10
Failure to separate 9
Close, difficult to 9
Defective item 9
Tear, rip or hole in device packaging 9
Material separation 9
Loose or intermittent connection 9
Component(s), broken 9
Blockage within device or device component 8
Unintended system motion 8
Device damaged prior to use 8
Failure to align 8
Expulsion 8
Power source issue 8
Packaging issue 8
Malposition of device 7
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
Difficult to insert 6
Defective component 6
Fitting problem 6
Connection issue 6
Device markings issue 5
Failure to disconnect 5
Torn material 5
Fail-safe mechanism issue 5
Material perforation 5
Loss of power 5
Unintended head motion 5
Hole in material 4
Material fragmentation 4
Disconnection 4
Failure to read input signal 4
Foreign material present in device 4
Total Device Problems 7510

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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