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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
APPLIED MEDICAL RESOURCES CORPORATION
  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 14
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 3
EZISURG (SUZHOU) MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
REACH SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIA SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUXI BEIEN SURGERY DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 16597 16597
2020 12327 12327
2021 13015 13015
2022 13608 13608
2023 14687 14687
2024 9034 9052

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 28187 28187
Failure to Form Staple 12611 12611
Misfire 8216 8216
Adverse Event Without Identified Device or Use Problem 7909 7909
Difficult to Open or Close 7856 7856
Break 4024 4024
Entrapment of Device 3227 3227
Detachment of Device or Device Component 3023 3023
Insufficient Information 2536 2536
Human-Device Interface Problem 2380 2380
Noise, Audible 1829 1829
Failure to Cut 1526 1526
Mechanical Jam 1480 1480
Complete Loss of Power 1444 1444
Failure to Charge 1248 1248
Device Displays Incorrect Message 1218 1218
Mechanics Altered 1159 1159
Firing Problem 1128 1128
No Apparent Adverse Event 1074 1074
Loss of or Failure to Bond 1060 1060
Component or Accessory Incompatibility 957 957
Ejection Problem 847 847
Material Integrity Problem 824 824
Difficult to Remove 732 732
Retraction Problem 731 731
Patient Device Interaction Problem 675 693
Expulsion 537 537
Activation Failure 535 535
Power Problem 523 523
Mechanical Problem 503 503
Material Twisted/Bent 418 418
Activation Problem 390 390
Physical Resistance/Sticking 361 361
Corroded 327 327
Device Difficult to Setup or Prepare 302 302
Difficult or Delayed Positioning 294 294
Positioning Failure 266 266
Failure to Align 264 264
Device Markings/Labelling Problem 262 262
Unintended Ejection 256 256
Device Slipped 255 255
Unintended Movement 250 250
Delivered as Unsterile Product 242 242
Failure to Power Up 231 231
Fluid/Blood Leak 226 226
Difficult to Insert 196 196
Appropriate Term/Code Not Available 193 193
Positioning Problem 176 176
Self-Activation or Keying 167 167
Product Quality Problem 166 166

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39016 39016
No Consequences Or Impact To Patient 18059 18059
Insufficient Information 4763 4763
Unspecified Tissue Injury 4614 4632
No Code Available 4579 4580
Failure to Anastomose 3631 3631
Hemorrhage/Bleeding 3287 3287
No Known Impact Or Consequence To Patient 2249 2249
Tissue Breakdown 1507 1507
Tissue Damage 1343 1343
No Information 1176 1176
Blood Loss 963 964
No Patient Involvement 921 921
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 553 553
Pain 524 524
Fistula 464 464
Unspecified Infection 366 366
Abscess 330 330
Laceration(s) 306 306
Foreign Body In Patient 295 295
Hematoma 291 291
Sepsis 276 276
Abdominal Pain 268 268
Fever 242 242
Obstruction/Occlusion 234 234
Unintended Radiation Exposure 189 189
Injury 171 171
Peritonitis 163 163
Hernia 162 162
Death 160 161
Inflammation 160 160
Wound Dehiscence 143 143
Vomiting 122 122
Pneumothorax 112 112
Seroma 111 111
Post Operative Wound Infection 105 105
Nausea 101 101
Tachycardia 100 100
Radiation Exposure, Unintended 99 99
Not Applicable 98 98
Adhesion(s) 95 95
Pleural Effusion 92 92
Low Blood Pressure/ Hypotension 86 86
Septic Shock 84 84
Pneumonia 77 77
Stenosis 75 75
Necrosis 75 75
Bowel Perforation 71 71
Device Embedded In Tissue or Plaque 70 70
Perforation 70 70

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Feb-18-2020
2 Covidien LLC II Jun-16-2019
3 Covidien Llc II Apr-13-2021
4 Covidien Llc II Dec-29-2020
5 Covidien, LP II May-24-2024
6 Covidien, LP II Apr-01-2024
7 Covidien, LP II Mar-06-2023
8 Covidien, LP II Apr-09-2021
9 Covidien, LP II Oct-01-2020
10 Ethicon Endo-Surgery Inc II Jan-26-2024
11 Ethicon Endo-Surgery Inc II Aug-19-2021
12 Ethicon Endo-Surgery Inc I Oct-29-2019
13 Ethicon Endo-Surgery Inc I May-15-2019
14 Ethicon Endo-Surgery Inc II Jan-08-2019
15 Smith & Nephew Inc. II Sep-10-2024
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