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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 3
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 14688 14688
2024 10290 10308

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 28608 28608
Failure to Form Staple 12795 12795
Misfire 8333 8333
Difficult to Open or Close 8100 8100
Adverse Event Without Identified Device or Use Problem 7980 7980
Break 4084 4084
Entrapment of Device 3275 3275
Detachment of Device or Device Component 3045 3045
Insufficient Information 2578 2578
Human-Device Interface Problem 2406 2406
Noise, Audible 1856 1856
Failure to Cut 1542 1542
Mechanical Jam 1503 1503
Complete Loss of Power 1449 1449
Failure to Charge 1251 1251
Device Displays Incorrect Message 1243 1243
Mechanics Altered 1171 1171
Firing Problem 1157 1157
No Apparent Adverse Event 1114 1114
Loss of or Failure to Bond 1060 1060
Component or Accessory Incompatibility 966 966
Ejection Problem 871 871
Material Integrity Problem 853 853
Retraction Problem 747 747
Difficult to Remove 732 732
Patient Device Interaction Problem 679 697
Activation Failure 546 546
Expulsion 545 545
Power Problem 523 523
Mechanical Problem 509 509
Material Twisted/Bent 422 422
Activation Problem 398 398
Physical Resistance/Sticking 362 362
Corroded 328 328
Device Difficult to Setup or Prepare 306 306
Difficult or Delayed Positioning 294 294
Positioning Failure 276 276
Unintended Ejection 267 267
Failure to Align 264 264
Device Markings/Labelling Problem 262 262
Delivered as Unsterile Product 256 256
Device Slipped 255 255
Unintended Movement 254 254
Failure to Power Up 232 232
Fluid/Blood Leak 226 226
Difficult to Insert 204 204
Appropriate Term/Code Not Available 195 195
Positioning Problem 181 181
Unintended System Motion 171 171
Product Quality Problem 170 170

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40013 40013
No Consequences Or Impact To Patient 18059 18059
Insufficient Information 4837 4837
Unspecified Tissue Injury 4642 4660
No Code Available 4579 4580
Failure to Anastomose 3654 3654
Hemorrhage/Bleeding 3372 3372
No Known Impact Or Consequence To Patient 2249 2249
Tissue Breakdown 1636 1636
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 555 555
Pain 526 526
Fistula 470 470
Unspecified Infection 369 369
Abscess 330 330
Laceration(s) 325 325
Foreign Body In Patient 303 303
Hematoma 292 292
Sepsis 277 277
Abdominal Pain 268 268
Fever 243 243
Obstruction/Occlusion 234 234
Unintended Radiation Exposure 189 189
Injury 171 171
Hernia 166 166
Peritonitis 163 163
Inflammation 161 161
Death 160 161
Wound Dehiscence 152 152
Vomiting 123 123
Pneumothorax 115 115
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) 96 96
Pleural Effusion 93 93
Low Blood Pressure/ Hypotension 86 86
Septic Shock 84 84
Pneumonia 77 77
Perforation 76 76
Necrosis 75 75
Stenosis 75 75
Bowel Perforation 71 71
Device Embedded In Tissue or Plaque 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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