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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
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOG ICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 7
COVIDIEN (PART OF MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 5
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIA SURGICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI BEIEN SURGERY DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 13015 13020
2022 13605 13621
2023 14623 14625
2024 13280 13300
2025 12055 12055
2026 4733 4734

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 24678 24683
Failure to Form Staple 11128 11132
Difficult to Open or Close 8343 8345
Adverse Event Without Identified Device or Use Problem 7541 7545
Misfire 7078 7082
Break 3597 3598
Insufficient Information 3037 3038
Entrapment of Device 2962 2962
Detachment of Device or Device Component 2324 2325
Human-Device Interface Problem 1904 1904
No Apparent Adverse Event 1895 1895
Noise, Audible 1625 1625
Failure to Cut 1376 1377
Firing Problem 1353 1354
Mechanical Jam 1300 1300
Complete Loss of Power 1262 1262
Device Displays Incorrect Message 1221 1221
Ejection Problem 1166 1166
Material Integrity Problem 1093 1093
Patient Device Interaction Problem 1063 1082
Mechanics Altered 989 990
Failure to Charge 934 934
Retraction Problem 767 767
Component or Accessory Incompatibility 683 683
Activation Failure 638 638
Activation Problem 474 474
Loss of or Failure to Bond 473 474
Difficult to Remove 452 452
Positioning Failure 427 427
Expulsion 414 414
Unintended Ejection 366 366
Delivered as Unsterile Product 365 365
Separation Problem 312 312
Device Markings/Labelling Problem 280 280
Unintended Movement 265 265
Device Difficult to Setup or Prepare 263 263
Unintended System Motion 260 260
Failure to Power Up 257 257
Material Twisted/Bent 248 248
Corroded 238 238
Computer Software Problem 227 227
Power Problem 220 220
Mechanical Problem 209 210
Appropriate Term/Code Not Available 208 209
Difficult to Insert 204 204
Device Slipped 201 201
Self-Activation or Keying 182 182
Difficult or Delayed Positioning 176 176
Failure to Align 168 168
Physical Resistance/Sticking 160 160

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52814 52824
Insufficient Information 6033 6038
Unspecified Tissue Injury 4937 4958
Hemorrhage/Bleeding 4872 4877
Failure to Anastomose 3382 3383
Tissue Breakdown 3279 3281
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 558 558
Laceration(s) 524 525
Fistula 411 411
Pain 388 388
Unspecified Infection 357 358
Foreign Body In Patient 348 350
Abscess 269 269
Obstruction/Occlusion 260 260
Unintended Radiation Exposure 258 258
Sepsis 247 247
Abdominal Pain 233 234
Hematoma 226 227
Fever 206 206
Wound Dehiscence 173 173
Hernia 162 162
Pneumothorax 152 152
Inflammation 150 150
Peritonitis 119 119
Vomiting 114 114
Tachycardia 101 101
Adhesion(s) 97 98
Nausea 97 97
Post Operative Wound Infection 96 96
Pleural Effusion 94 94
Seroma 91 91
Low Blood Pressure/ Hypotension 88 88
Perforation 85 86
Stenosis 83 83
Anemia 79 79
Pneumonia 73 73
Necrosis 67 67
Abdominal Distention 65 65
Fluid Discharge 64 64
Ulcer 60 60
Bowel Perforation 58 58
Impaired Healing 58 58
Thrombosis/Thrombus 57 57
Cardiac Arrest 57 57
Septic Shock 56 56
Diarrhea 55 55
Swelling/ Edema 54 54
Urinary Tract Infection 54 54
Bacterial Infection 50 50
Ascites 49 49

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Apr-13-2021
2 Covidien, LP II Nov-07-2025
3 Covidien, LP II May-24-2024
4 Covidien, LP II Apr-01-2024
5 Covidien, LP II Mar-06-2023
6 Covidien, LP II Apr-09-2021
7 Ethicon Endo-Surgery Inc II Oct-14-2025
8 Ethicon Endo-Surgery Inc I May-20-2025
9 Ethicon Endo-Surgery Inc II Jan-26-2024
10 Ethicon Endo-Surgery Inc II Aug-19-2021
11 Smith & Nephew Inc. II Sep-10-2024
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