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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 4609 4627

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 26684 26684
Failure to Form Staple 12011 12011
Misfire 7769 7769
Adverse Event Without Identified Device or Use Problem 7524 7524
Difficult to Open or Close 7220 7220
Break 3767 3767
Entrapment of Device 2998 2998
Detachment of Device or Device Component 2928 2928
Insufficient Information 2333 2333
Human-Device Interface Problem 2288 2288
Noise, Audible 1724 1724
Failure to Cut 1454 1454
Mechanical Jam 1427 1427
Complete Loss of Power 1418 1418
Failure to Charge 1236 1236
Device Displays Incorrect Message 1128 1128
Mechanics Altered 1077 1077
Loss of or Failure to Bond 1050 1050
Firing Problem 1032 1032
No Apparent Adverse Event 961 961
Component or Accessory Incompatibility 925 925
Ejection Problem 782 782
Material Integrity Problem 745 745
Difficult to Remove 715 715
Retraction Problem 661 661
Patient Device Interaction Problem 630 648
Power Problem 520 520
Activation Failure 508 508
Expulsion 502 502
Mechanical Problem 493 493
Material Twisted/Bent 400 400
Activation Problem 369 369
Physical Resistance/Sticking 360 360
Corroded 325 325
Difficult or Delayed Positioning 294 294
Device Difficult to Setup or Prepare 290 290
Failure to Align 263 263
Device Markings/Labelling Problem 258 258
Unintended Movement 240 240
Positioning Failure 237 237
Device Slipped 233 233
Unintended Ejection 232 232
Failure to Power Up 227 227
Fluid/Blood Leak 226 226
Delivered as Unsterile Product 202 202
Appropriate Term/Code Not Available 187 187
Positioning Problem 173 173
Difficult to Insert 165 165
Product Quality Problem 163 163
Activation, Positioning or Separation Problem 158 158
Gas/Air Leak 155 155
Tear, Rip or Hole in Device Packaging 150 150
Self-Activation or Keying 149 149
Device Misassembled During Manufacturing /Shipping 147 147
Nonstandard Device 146 146
Defective Device 141 141
Unintended System Motion 133 133
Failure to Read Input Signal 131 131
Computer Software Problem 113 113
Failure to Eject 113 113
Leak/Splash 111 111
Separation Problem 106 106
Material Separation 102 102
Component Missing 98 98
Manufacturing, Packaging or Shipping Problem 95 95
No Display/Image 94 94
Electrical /Electronic Property Problem 85 85
Failure to Cycle 83 83
Material Protrusion/Extrusion 80 80
Difficult or Delayed Activation 77 77
Therapeutic or Diagnostic Output Failure 71 71
Structural Problem 70 70
Overheating of Device 70 70
Premature End-of-Life Indicator 67 67
Separation Failure 67 67
Use of Device Problem 67 67
Failure to Advance 62 62
No Device Output 62 62
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Material Fragmentation 58 58
Battery Problem 58 58
Unraveled Material 54 54
Fail-Safe Problem 53 53
Protective Measures Problem 53 53
Excessive Heating 52 52
Device Fell 52 52
Material Deformation 51 51
Device Contamination with Chemical or Other Material 48 48
Premature Activation 47 47
Loose or Intermittent Connection 44 44
Output Problem 43 43
Display or Visual Feedback Problem 42 42
Patient-Device Incompatibility 41 41
Material Split, Cut or Torn 38 38
Defective Component 37 37
Application Program Version or Upgrade Problem 36 36
Calibration Problem 34 34
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 35706 35706
No Consequences Or Impact To Patient 18059 18059
No Code Available 4579 4580
Unspecified Tissue Injury 4482 4500
Insufficient Information 4461 4461
Failure to Anastomose 3497 3497
Hemorrhage/Bleeding 2904 2904
No Known Impact Or Consequence To Patient 2249 2249
Tissue Damage 1343 1343
No Information 1176 1176
Tissue Breakdown 1047 1047
Blood Loss 963 964
No Patient Involvement 921 921
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 510 510
Pain 501 501
Fistula 455 455
Unspecified Infection 346 346
Abscess 312 312
Foreign Body In Patient 273 273
Hematoma 272 272
Laceration(s) 260 260
Abdominal Pain 250 250
Sepsis 248 248
Fever 232 232
Obstruction/Occlusion 217 217
Unintended Radiation Exposure 173 173
Injury 171 171
Death 160 161
Peritonitis 155 155
Hernia 152 152
Inflammation 144 144
Wound Dehiscence 123 123
Vomiting 113 113
Seroma 109 109
Pneumothorax 106 106
Post Operative Wound Infection 103 103
Radiation Exposure, Unintended 99 99
Not Applicable 98 98
Tachycardia 95 95
Nausea 92 92
Pleural Effusion 83 83
Septic Shock 80 80
Adhesion(s) 78 78
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 65 65
Stenosis 64 64
Perforation 56 56
Diarrhea 55 55
Impaired Healing 55 55
Pulmonary Emphysema 54 54
Incontinence 53 53
Fluid Discharge 53 53
Abdominal Distention 52 52
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
Rectal Anastomotic Leakage 28 28
Organ Dehiscence 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 13 13
Cancer 13 13
Weight Changes 13 13
Syncope/Fainting 13 13
Chills 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 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 Ethicon Endo-Surgery Inc I Oct-29-2019
12 Ethicon Endo-Surgery Inc I May-15-2019
13 Ethicon Endo-Surgery Inc II Jan-08-2019
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