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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 BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 12
ETHICON ENDO- SURGERY. LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 3
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEXINGTON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
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
2020 12327 12327
2021 13015 13015
2022 13606 13606
2023 14692 14692
2024 13329 13347
2025 3044 3044

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 24541 24541
Failure to Form Staple 10959 10959
Difficult to Open or Close 7840 7840
Adverse Event Without Identified Device or Use Problem 7203 7203
Misfire 7079 7079
Break 3683 3683
Entrapment of Device 3031 3031
Insufficient Information 2690 2690
Detachment of Device or Device Component 2481 2481
Human-Device Interface Problem 2017 2017
Noise, Audible 1557 1557
Complete Loss of Power 1420 1420
Failure to Cut 1361 1361
Mechanical Jam 1301 1301
No Apparent Adverse Event 1284 1284
Failure to Charge 1256 1256
Device Displays Incorrect Message 1169 1169
Firing Problem 1064 1064
Mechanics Altered 1010 1010
Ejection Problem 999 999
Material Integrity Problem 961 961
Patient Device Interaction Problem 809 827
Component or Accessory Incompatibility 774 774
Loss of or Failure to Bond 683 683
Retraction Problem 644 644
Activation Failure 582 582
Difficult to Remove 530 530
Power Problem 521 521
Expulsion 460 460
Activation Problem 416 416
Corroded 329 329
Unintended Ejection 323 323
Mechanical Problem 318 318
Material Twisted/Bent 294 294
Delivered as Unsterile Product 290 290
Positioning Failure 278 278
Device Markings/Labelling Problem 259 259
Device Difficult to Setup or Prepare 249 249
Failure to Power Up 239 239
Unintended Movement 228 228
Difficult or Delayed Positioning 212 212
Device Slipped 212 212
Failure to Align 208 208
Difficult to Insert 203 203
Physical Resistance/Sticking 194 194
Separation Problem 188 188
Unintended System Motion 187 187
Computer Software Problem 176 176
Appropriate Term/Code Not Available 169 169
Product Quality Problem 158 158

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44710 44710
No Consequences Or Impact To Patient 7653 7653
Insufficient Information 5251 5251
Unspecified Tissue Injury 4786 4804
Hemorrhage/Bleeding 3752 3752
Failure to Anastomose 3203 3203
Tissue Breakdown 2093 2093
No Code Available 1600 1600
No Patient Involvement 663 663
Tissue Damage 609 609
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 570 570
No Information 559 559
Fistula 416 416
Pain 382 382
Laceration(s) 371 371
Blood Loss 339 339
Unspecified Infection 311 311
Foreign Body In Patient 294 294
Abscess 281 281
Sepsis 233 233
Abdominal Pain 225 225
Obstruction/Occlusion 216 216
Fever 213 213
Hematoma 207 207
Unintended Radiation Exposure 204 204
No Known Impact Or Consequence To Patient 162 162
Inflammation 153 153
Wound Dehiscence 145 145
Hernia 144 144
Peritonitis 131 131
Pneumothorax 121 121
Vomiting 108 108
Tachycardia 97 97
Pleural Effusion 95 95
Nausea 94 94
Post Operative Wound Infection 93 93
Seroma 92 92
Adhesion(s) 89 89
Injury 88 88
Pneumonia 80 80
Low Blood Pressure/ Hypotension 80 80
Anemia 74 74
Perforation 69 69
Necrosis 67 67
Stenosis 65 65
Fluid Discharge 65 65
Abdominal Distention 64 64
Septic Shock 62 62
Impaired Healing 59 59
Diarrhea 58 58

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Feb-18-2020
2 Covidien Llc II Apr-13-2021
3 Covidien Llc II Dec-29-2020
4 Covidien, LP II May-24-2024
5 Covidien, LP II Apr-01-2024
6 Covidien, LP II Mar-06-2023
7 Covidien, LP II Apr-09-2021
8 Covidien, LP II Oct-01-2020
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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