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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device staple, implantable
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
  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 14694 14694
2024 13332 13350

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 23552 23552
Failure to Form Staple 10569 10569
Difficult to Open or Close 7425 7425
Adverse Event Without Identified Device or Use Problem 6900 6900
Misfire 6830 6830
Break 3509 3509
Entrapment of Device 2933 2933
Insufficient Information 2605 2605
Detachment of Device or Device Component 2404 2404
Human-Device Interface Problem 1967 1967
Noise, Audible 1524 1524
Complete Loss of Power 1387 1387
Failure to Cut 1324 1324
Mechanical Jam 1252 1252
Failure to Charge 1242 1242
No Apparent Adverse Event 1202 1202
Device Displays Incorrect Message 1125 1125
Firing Problem 983 983
Mechanics Altered 983 983
Ejection Problem 946 946
Material Integrity Problem 913 913
Component or Accessory Incompatibility 755 755
Patient Device Interaction Problem 694 712
Loss of or Failure to Bond 684 684
Retraction Problem 584 584
Activation Failure 568 568
Power Problem 521 521
Difficult to Remove 519 519
Expulsion 443 443
Activation Problem 390 390
Corroded 328 328
Mechanical Problem 315 315
Unintended Ejection 291 291
Material Twisted/Bent 291 291
Delivered as Unsterile Product 273 273
Device Markings/Labelling Problem 259 259
Positioning Failure 256 256
Device Difficult to Setup or Prepare 237 237
Failure to Power Up 232 232
Difficult or Delayed Positioning 211 211
Failure to Align 207 207
Device Slipped 205 205
Unintended Movement 197 197
Difficult to Insert 194 194
Physical Resistance/Sticking 190 190
Unintended System Motion 169 169
Appropriate Term/Code Not Available 168 168
Separation Problem 165 165
Product Quality Problem 156 156
Computer Software Problem 155 155

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42417 42417
No Consequences Or Impact To Patient 7653 7653
Insufficient Information 5006 5006
Unspecified Tissue Injury 4717 4735
Hemorrhage/Bleeding 3514 3514
Failure to Anastomose 3064 3064
Tissue Breakdown 1866 1866
No Code Available 1600 1600
No Patient Involvement 663 663
Tissue Damage 609 609
No Information 559 559
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 556 556
Fistula 384 384
Pain 371 371
Laceration(s) 353 353
Blood Loss 339 339
Unspecified Infection 282 282
Foreign Body In Patient 282 282
Abscess 261 261
Sepsis 226 226
Abdominal Pain 213 213
Fever 205 205
Hematoma 199 199
Obstruction/Occlusion 198 198
Unintended Radiation Exposure 191 191
No Known Impact Or Consequence To Patient 162 162
Inflammation 144 144
Hernia 139 139
Wound Dehiscence 126 126
Peritonitis 124 124
Pneumothorax 116 116
Vomiting 101 101
Tachycardia 93 93
Seroma 90 90
Injury 88 88
Post Operative Wound Infection 87 87
Nausea 87 87
Adhesion(s) 85 85
Pleural Effusion 85 85
Low Blood Pressure/ Hypotension 75 75
Pneumonia 74 74
Necrosis 64 64
Stenosis 62 62
Perforation 61 61
Anemia 61 61
Septic Shock 61 61
Abdominal Distention 59 59
Impaired Healing 59 59
Fluid Discharge 59 59
Bowel Perforation 57 57

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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