• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device staple, implantable
Regulation Description Implantable staple.
Product CodeGDW
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 7
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 4
DEXTERA SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
ETHICON
  SUBSTANTIALLY EQUIVALENT 7
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 6
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GOLDEN STAPLER SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JUSTRIGHT SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEXINGTON MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
OPUS KSD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VIA SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to Fire 12537
Failure to Form Staple 4010
Misfire 3616
Difficult to Open or Close 2244
Adverse Event Without Identified Device or Use Problem 1527
Human-Device Interface Problem 1498
Noise, Audible 1414
Break 1315
Entrapment of Device 1235
Detachment Of Device Component 813
Mechanics Altered 811
Failure To Adhere Or Bond 643
Detachment of Device or device Component 601
Device Displays Incorrect Message 469
Difficult to Remove 463
Fluid Leak 328
Loss of or Failure to Bond 312
Failure to Cut 308
Failure to Cycle 304
Device Operates Differently Than Expected 259
Retraction Problem 224
Device Difficult to Setup or Prepare 220
Difficult or Delayed Positioning 217
Component or Accessory Incompatibility 217
Expulsion 199
Unintended Movement 194
Device Inoperable 158
Bent 140
Mechanical Jam 134
Positioning Problem 132
Use of Device Problem 121
Mechanical Problem 109
Insufficient Information 104
Positioning Failure 104
Physical Resistance 103
Failure to Sense 92
Device Stops Intermittently 86
Air Leak 86
Device Slipped 83
Appropriate Term/Code Not Available 79
Failure to Align 75
Gas Leak 72
Unintended System Motion 71
Failure to Read Input Signal 70
Difficult To Position 69
Material Twisted / Bent 60
Fail-Safe Problem 60
Difficult to Advance 57
Failure to Advance 56
Leak / Splash 54
Complete Loss of power 51
Unintended Arm Motion 51
Physical Resistance / Sticking 48
Separation Failure 47
Component Missing 45
Sticking 44
Jaw 41
Calibration Problem 40
Difficult or Delayed Activation 35
Unintended Head Motion 33
Failure to Charge 31
Failure to Calibrate 30
Difficult to Insert 29
Staple 28
Knife 27
Material Deformation 27
Power Problem 24
Overheating of Device 21
Product Quality Problem 20
Calibration Error 19
Component Falling 19
Protective Measures Problem 19
Material Separation 18
Packaging Problem 18
Extrusion 18
Self-Activation or Keying 17
Material Protrusion / Extrusion 16
Activation, Positioning or Separation Problem 15
Tear, Rip or Hole in Device Packaging 14
Device Contamination with Chemical or Other Material 14
Premature End-of-Life Indicator 13
Device Misassembled During Manufacturing / Shipping 12
Device Remains Activated 12
Device Packaging Compromised 11
Device Handling Problem 11
Switch, Push Button 11
Display or Visual Feedback Problem 11
Premature Activation 10
Defective Device 10
Material Fragmentation 10
Knob 10
No Display / Image 10
Improper or Incorrect Procedure or Method 10
Migration or Expulsion of Device 10
Contamination / decontamination Problem 9
Failure to Power Up 9
Device Damaged Prior to Use 9
Incorrect, Inadequate or Imprecise Result or Readings 8
Misassembly by Users 8
Clip 7
Total Device Problems 39213

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN MEDTRONIC II Jul-19-2018
2 COVIDIEN MEDTRONIC II May-16-2018
3 Cardica, Inc. II Dec-24-2015
4 Covidien LLC II Jun-16-2019
5 Covidien LLC II Apr-26-2018
6 Covidien LLC II Mar-27-2018
7 Covidien LLC II Mar-06-2018
8 Covidien LLC II Feb-16-2018
9 EXP Pharmaceutical Services Corp II Jul-24-2015
10 Ethicon Endo-Surgery Inc I May-15-2019
11 Ethicon Endo-Surgery Inc II Jan-08-2019
12 Ethicon Endo-Surgery Inc II Feb-21-2018
13 Ethicon Endo-Surgery Inc II May-31-2017
14 Ethicon Endo-Surgery Inc II Oct-20-2016
15 Ethicon Endo-Surgery Inc II May-21-2015
16 Incisive Surgical Inc II Oct-05-2018
17 Incisive Surgical Inc II Apr-29-2015
18 Intuitive Surgical, Inc. II Jul-06-2018
19 Justright Surgical, LLC II Jul-02-2015
20 Justright Surgical, LLC II Sep-23-2014
21 Laax, Inc. I Apr-23-2015
22 Medtronic II Feb-18-2016

-
-