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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
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 4
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 12057 12057

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 23319 23324
Failure to Form Staple 10365 10369
Difficult to Open or Close 7835 7837
Adverse Event Without Identified Device or Use Problem 7026 7029
Misfire 6645 6649
Break 3380 3381
Insufficient Information 2846 2847
Entrapment of Device 2815 2815
Detachment of Device or Device Component 2219 2220
Human-Device Interface Problem 1816 1816
No Apparent Adverse Event 1670 1670
Noise, Audible 1508 1508
Failure to Cut 1262 1263
Complete Loss of Power 1226 1226
Mechanical Jam 1215 1215
Firing Problem 1155 1156
Device Displays Incorrect Message 1154 1154
Ejection Problem 1069 1069
Material Integrity Problem 1018 1018
Patient Device Interaction Problem 994 1013
Mechanics Altered 960 960
Failure to Charge 917 917
Component or Accessory Incompatibility 648 648
Retraction Problem 645 645
Activation Failure 606 606
Loss of or Failure to Bond 473 474
Activation Problem 439 439
Difficult to Remove 424 424
Expulsion 395 395
Positioning Failure 375 375
Unintended Ejection 344 344
Delivered as Unsterile Product 327 327
Separation Problem 260 260
Device Markings/Labelling Problem 251 251
Failure to Power Up 250 250
Corroded 238 238
Material Twisted/Bent 237 237
Unintended System Motion 232 232
Unintended Movement 228 228
Device Difficult to Setup or Prepare 224 224
Power Problem 219 219
Computer Software Problem 215 215
Mechanical Problem 198 199
Difficult to Insert 191 191
Device Slipped 190 190
Difficult or Delayed Positioning 175 175
Appropriate Term/Code Not Available 172 173
Self-Activation or Keying 170 170
Failure to Align 163 163
Physical Resistance/Sticking 147 147

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49334 49344
Insufficient Information 5753 5758
Unspecified Tissue Injury 4770 4791
Hemorrhage/Bleeding 4426 4431
Failure to Anastomose 3199 3200
Tissue Breakdown 2827 2828
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 553 553
Laceration(s) 490 491
Fistula 390 390
Pain 359 359
Unspecified Infection 324 325
Foreign Body In Patient 319 321
Abscess 263 263
Obstruction/Occlusion 241 241
Sepsis 232 232
Abdominal Pain 220 221
Unintended Radiation Exposure 219 219
Hematoma 214 215
Fever 197 197
Hernia 154 154
Wound Dehiscence 152 152
Inflammation 142 142
Pneumothorax 135 135
Peritonitis 116 116
Vomiting 108 108
Tachycardia 95 95
Nausea 95 95
Adhesion(s) 94 95
Pleural Effusion 94 94
Seroma 86 86
Low Blood Pressure/ Hypotension 86 86
Post Operative Wound Infection 85 85
Perforation 79 80
Stenosis 77 77
Anemia 75 75
Pneumonia 70 70
Necrosis 65 65
Fluid Discharge 64 64
Abdominal Distention 63 63
Bowel Perforation 58 58
Impaired Healing 58 58
Ulcer 57 57
Cardiac Arrest 55 55
Urinary Tract Infection 54 54
Diarrhea 54 54
Thrombosis/Thrombus 53 53
Septic Shock 53 53
Ascites 49 49
Swelling/ Edema 49 49
Bacterial Infection 46 46

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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