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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 5668 5686

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 27055 27055
Failure to Form Staple 12157 12157
Misfire 7882 7882
Adverse Event Without Identified Device or Use Problem 7607 7607
Difficult to Open or Close 7345 7345
Break 3838 3838
Entrapment of Device 3060 3060
Detachment of Device or Device Component 2951 2951
Insufficient Information 2379 2379
Human-Device Interface Problem 2315 2315
Noise, Audible 1757 1757
Failure to Cut 1465 1465
Mechanical Jam 1447 1447
Complete Loss of Power 1422 1422
Failure to Charge 1238 1238
Device Displays Incorrect Message 1153 1153
Mechanics Altered 1099 1099
Loss of or Failure to Bond 1056 1056
Firing Problem 1048 1048
No Apparent Adverse Event 980 980
Component or Accessory Incompatibility 930 930
Ejection Problem 796 796
Material Integrity Problem 767 767
Difficult to Remove 719 719
Retraction Problem 675 675
Patient Device Interaction Problem 636 654
Power Problem 520 520
Expulsion 517 517
Activation Failure 516 516
Mechanical Problem 496 496
Material Twisted/Bent 408 408
Activation Problem 373 373
Physical Resistance/Sticking 360 360
Corroded 325 325
Difficult or Delayed Positioning 294 294
Device Difficult to Setup or Prepare 292 292
Failure to Align 263 263
Device Markings/Labelling Problem 259 259
Unintended Movement 245 245
Positioning Failure 242 242
Device Slipped 239 239
Unintended Ejection 236 236
Failure to Power Up 227 227
Fluid/Blood Leak 226 226
Delivered as Unsterile Product 205 205
Appropriate Term/Code Not Available 187 187
Difficult to Insert 176 176
Positioning Problem 174 174
Product Quality Problem 163 163
Activation, Positioning or Separation Problem 158 158
Gas/Air Leak 155 155
Tear, Rip or Hole in Device Packaging 151 151
Self-Activation or Keying 151 151
Device Misassembled During Manufacturing /Shipping 148 148
Nonstandard Device 146 146
Defective Device 141 141
Unintended System Motion 139 139
Failure to Read Input Signal 136 136
Computer Software Problem 127 127
Failure to Eject 113 113
Separation Problem 111 111
Leak/Splash 111 111
Material Separation 103 103
Component Missing 98 98
No Display/Image 96 96
Manufacturing, Packaging or Shipping Problem 96 96
Electrical /Electronic Property Problem 86 86
Failure to Cycle 83 83
Material Protrusion/Extrusion 82 82
Structural Problem 77 77
Difficult or Delayed Activation 77 77
Therapeutic or Diagnostic Output Failure 71 71
Overheating of Device 70 70
Use of Device Problem 69 69
Separation Failure 68 68
Premature End-of-Life Indicator 67 67
No Device Output 64 64
Failure to Advance 62 62
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Material Fragmentation 60 60
Battery Problem 58 58
Material Deformation 58 58
Unraveled Material 54 54
Fail-Safe Problem 53 53
Protective Measures Problem 53 53
Excessive Heating 52 52
Device Fell 52 52
Premature Activation 50 50
Device Contamination with Chemical or Other Material 48 48
Display or Visual Feedback Problem 45 45
Loose or Intermittent Connection 44 44
Patient-Device Incompatibility 43 43
Output Problem 43 43
Material Split, Cut or Torn 39 39
Defective Component 37 37
Application Program Version or Upgrade Problem 36 36
Calibration Problem 35 35
Device Remains Activated 34 34
Difficult to Advance 33 33
Packaging Problem 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36512 36512
No Consequences Or Impact To Patient 18059 18059
No Code Available 4579 4580
Insufficient Information 4527 4527
Unspecified Tissue Injury 4506 4524
Failure to Anastomose 3533 3533
Hemorrhage/Bleeding 2990 2990
No Known Impact Or Consequence To Patient 2249 2249
Tissue Damage 1343 1343
No Information 1176 1176
Tissue Breakdown 1170 1170
Blood Loss 963 964
No Patient Involvement 921 921
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 515 515
Pain 503 503
Fistula 456 456
Unspecified Infection 349 349
Abscess 313 313
Foreign Body In Patient 276 276
Hematoma 275 275
Laceration(s) 271 271
Abdominal Pain 252 252
Sepsis 249 249
Fever 233 233
Obstruction/Occlusion 218 218
Unintended Radiation Exposure 174 174
Injury 171 171
Death 160 161
Peritonitis 155 155
Hernia 152 152
Inflammation 144 144
Wound Dehiscence 124 124
Vomiting 114 114
Seroma 109 109
Pneumothorax 107 107
Post Operative Wound Infection 103 103
Radiation Exposure, Unintended 99 99
Not Applicable 98 98
Tachycardia 96 96
Nausea 92 92
Pleural Effusion 84 84
Septic Shock 80 80
Adhesion(s) 79 79
Pneumonia 77 77
Low Blood Pressure/ Hypotension 74 74
Bowel Perforation 71 71
Device Embedded In Tissue or Plaque 70 70
Necrosis 68 68
Anemia 66 66
Stenosis 64 64
Abdominal Distention 56 56
Perforation 56 56
Diarrhea 55 55
Impaired Healing 55 55
Pulmonary Emphysema 54 54
Incontinence 53 53
Fluid Discharge 53 53
Urinary Tract Infection 51 51
High Blood Pressure/ Hypertension 44 44
Ulcer 44 44
Ischemia 42 42
Urinary Retention 41 41
Thrombosis/Thrombus 41 41
Cardiac Arrest 40 40
Bacterial Infection 39 39
Renal Failure 37 37
Dyspnea 36 36
Swelling/ Edema 36 36
Purulent Discharge 35 35
Thrombosis 35 35
Pulmonary Embolism 33 33
Ascites 33 33
Discomfort 33 33
Respiratory Failure 31 31
Perforation of Vessels 31 31
Exsanguination 29 29
Distress 29 29
Unspecified Respiratory Problem 29 29
Organ Dehiscence 28 28
Rectal Anastomotic Leakage 28 28
Dehydration 23 23
Failure of Implant 23 23
Myocardial Infarction 22 22
Shock 22 22
Emotional Changes 19 19
Swelling 18 18
Scar Tissue 17 17
Muscle Weakness 16 16
Hypoxia 16 16
Chest Pain 16 16
Dysphagia/ Odynophagia 15 15
Itching Sensation 15 15
Anxiety 15 15
Fibrosis 15 15
Hypersensitivity/Allergic reaction 14 14
Ecchymosis 14 14
Erythema 13 13
Cancer 13 13
Weight Changes 13 13
Syncope/Fainting 13 13

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
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