• 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
Product CodeGDW
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD INC,
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU KANGDI MEDICAL STAPLER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING QMI SURGICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 14
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
DEXTERA SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 6
EZISURG (SUZHOU) MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GOLDEN STAPLER SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEXINGTON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
LEXINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NINGBO VERYKIND MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
REACH SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TGS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIA SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
VIEWPOINT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WUXI BEIEN SURGERY DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 11641 11641
2018 14912 14912
2019 16597 16597
2020 12351 12351
2021 13047 13047
2022 7616 7616

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 28156 28156
Failure to Form Staple 12755 12755
Misfire 8013 8013
Difficult to Open or Close 6500 6500
Adverse Event Without Identified Device or Use Problem 5820 5820
Break 3816 3816
Human-Device Interface Problem 2727 2727
Entrapment of Device 2688 2688
Detachment of Device or Device Component 2446 2446
Noise, Audible 2271 2271
Mechanical Jam 1487 1487
Firing Problem 1439 1439
Mechanics Altered 1365 1365
Failure to Cut 1325 1325
Insufficient Information 1155 1155
Complete Loss of Power 1120 1120
Failure to Charge 1054 1054
Difficult to Remove 938 938
Detachment Of Device Component 937 937
Loss of or Failure to Bond 925 925
Device Displays Incorrect Message 867 867
Retraction Problem 854 854
Component or Accessory Incompatibility 754 754
Device Operates Differently Than Expected 677 677
Mechanical Problem 671 671
Power Problem 527 527
Fluid Leak 501 501
Expulsion 499 499
Failure To Adhere Or Bond 479 479
Difficult or Delayed Positioning 430 430
No Apparent Adverse Event 402 402
Ejection Problem 391 391
Device Difficult to Setup or Prepare 388 388
Physical Resistance/Sticking 375 375
Material Twisted/Bent 355 355
Material Integrity Problem 352 352
Unintended Movement 304 304
Patient Device Interaction Problem 297 297
Corroded 292 292
Positioning Problem 265 265
Activation Failure 261 261
Failure to Align 249 249
Device Inoperable 247 247
Leak/Splash 235 235
Positioning Failure 233 233
Appropriate Term/Code Not Available 231 231
Device Slipped 226 226
Activation, Positioning or SeparationProblem 217 217
Gas Leak 207 207
Activation Problem 206 206
Defective Device 200 200
Failure to Power Up 182 182
Bent 155 155
Failure to Advance 153 153
Nonstandard Device 146 146
Component Missing 136 136
Failure to Read Input Signal 135 135
Product Quality Problem 133 133
Difficult to Insert 122 122
Unintended Ejection 120 120
Unintended System Motion 114 114
Physical Resistance 114 114
Loose or Intermittent Connection 105 105
Delivered as Unsterile Product 100 100
Sticking 99 99
Overheating of Device 97 97
Fail-Safe Problem 95 95
Failure to Cycle 95 95
Material Protrusion/Extrusion 93 93
Device Misassembled During Manufacturing /Shipping 93 93
Material Deformation 91 91
Material Separation 87 87
Failure to Sense 85 85
Self-Activation or Keying 85 85
No Display/Image 85 85
Separation Failure 84 84
Air Leak 83 83
Battery Problem 80 80
Device Fell 72 72
Device Markings/Labelling Problem 71 71
Failure to Eject 70 70
Therapeutic or Diagnostic Output Failure 70 70
Incorrect, Inadequate or Imprecise Resultor Readings 69 69
Difficult to Advance 68 68
Defective Component 68 68
Use of Device Problem 66 66
Component Falling 65 65
Electrical /Electronic Property Problem 63 63
Difficult or Delayed Activation 63 63
Fitting Problem 63 63
Difficult To Position 62 62
Premature End-of-Life Indicator 61 61
Manufacturing, Packaging or Shipping Problem 61 61
Device Contamination with Chemical or Other Material 60 60
Patient-Device Incompatibility 53 53
Protective Measures Problem 52 52
Tear, Rip or Hole in Device Packaging 52 52
Material Fragmentation 51 51
Packaging Problem 48 48
Separation Problem 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 24318 24318
No Known Impact Or Consequence To Patient 18432 18432
No Clinical Signs, Symptoms or Conditions 17255 17255
No Code Available 8204 8205
Tissue Damage 2577 2577
Failure to Anastomose 2479 2479
Unspecified Tissue Injury 2412 2412
Insufficient Information 2143 2143
Blood Loss 1766 1768
No Information 1421 1421
Hemorrhage/Bleeding 1398 1398
No Patient Involvement 1302 1302
Injury 476 476
Fistula 395 395
Pain 385 385
Death 277 279
Unspecified Infection 271 271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 267 267
Abscess 263 263
Hematoma 231 231
Sepsis 213 213
Foreign Body In Patient 182 182
Abdominal Pain 176 176
Fever 168 168
Obstruction/Occlusion 167 167
Radiation Exposure, Unintended 163 163
Not Applicable 159 159
Wound Dehiscence 147 147
Peritonitis 141 141
Post Operative Wound Infection 109 109
Inflammation 97 97
Unintended Radiation Exposure 97 97
Vomiting 83 83
Hernia 81 81
Tachycardia 75 75
Bowel Perforation 65 65
Incontinence 64 64
Device Embedded In Tissue or Plaque 63 63
Septic Shock 60 60
Nausea 58 58
Necrosis 57 57
Adhesion(s) 56 56
Seroma 55 55
Exsanguination 55 55
Stenosis 54 54
Low Blood Pressure/ Hypotension 52 52
Pleural Effusion 51 51
Perforation 46 46
Laceration(s) 43 43
Anemia 40 40
Thrombosis 40 40
Pneumonia 39 39
Pneumothorax 34 34
Urinary Retention 33 33
Fluid Discharge 31 31
Cardiac Arrest 31 31
Abdominal Distention 30 30
Ischemia 29 29
Ulcer 26 26
Pulmonary Emphysema 26 26
Respiratory Failure 23 23
Purulent Discharge 23 23
Impaired Healing 22 22
Renal Failure 22 22
Shock 22 22
Bacterial Infection 22 22
Dyspnea 21 21
Urinary Tract Infection 20 20
High Blood Pressure/ Hypertension 20 20
Discomfort 19 19
Swelling 19 19
Organ Dehiscence 18 18
Ascites 18 18
Diarrhea 17 17
Failure of Implant 17 17
Swelling/ Edema 17 17
Scar Tissue 15 15
Itching Sensation 14 14
Hemostasis 13 13
Chest Pain 12 12
Distress 12 12
Cancer 12 12
Rectal Anastomotic Leakage 12 12
Edema 12 12
Chills 12 12
Dehydration 12 12
Thrombosis/Thrombus 11 11
Patient Problem/Medical Problem 11 11
Reaction 11 11
Granuloma 11 11
Fibrosis 10 10
Anxiety 10 10
Perforation of Vessels 10 10
Pulmonary Embolism 10 10
Constipation 9 9
Internal Organ Perforation 9 9
Hypoxia 9 9
Rash 9 9
Dysphagia/ Odynophagia 9 9
Scarring 9 9

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Feb-18-2020
2 COVIDIEN MEDTRONIC II Jul-19-2018
3 COVIDIEN MEDTRONIC II May-16-2018
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 Covidien Llc II Apr-13-2021
10 Covidien Llc II Dec-29-2020
11 Covidien, LP II Apr-09-2021
12 Covidien, LP II Oct-01-2020
13 Ethicon Endo-Surgery Inc II Aug-19-2021
14 Ethicon Endo-Surgery Inc I Oct-29-2019
15 Ethicon Endo-Surgery Inc I May-15-2019
16 Ethicon Endo-Surgery Inc II Jan-08-2019
17 Ethicon Endo-Surgery Inc II Feb-21-2018
18 Ethicon Endo-Surgery Inc II May-31-2017
19 Incisive Surgical Inc II Oct-05-2018
20 Intuitive Surgical, Inc. II Jul-06-2018
-
-