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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 3458 3458

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 26279 26279
Failure to Form Staple 11802 11802
Misfire 7687 7687
Adverse Event Without Identified Device or Use Problem 7410 7410
Difficult to Open or Close 7036 7036
Break 3725 3725
Entrapment of Device 2938 2938
Detachment of Device or Device Component 2900 2900
Insufficient Information 2289 2289
Human-Device Interface Problem 2265 2265
Noise, Audible 1701 1701
Failure to Cut 1432 1432
Complete Loss of Power 1411 1411
Mechanical Jam 1398 1398
Failure to Charge 1231 1231
Device Displays Incorrect Message 1103 1103
Mechanics Altered 1059 1059
Loss of or Failure to Bond 1047 1047
Firing Problem 1013 1013
No Apparent Adverse Event 949 949
Component or Accessory Incompatibility 910 910
Ejection Problem 763 763
Material Integrity Problem 725 725
Difficult to Remove 713 713
Retraction Problem 651 651
Patient Device Interaction Problem 611 611
Power Problem 520 520
Expulsion 498 498
Activation Failure 496 496
Mechanical Problem 489 489
Material Twisted/Bent 400 400
Activation Problem 363 363
Physical Resistance/Sticking 359 359
Corroded 324 324
Difficult or Delayed Positioning 294 294
Device Difficult to Setup or Prepare 285 285
Failure to Align 262 262
Device Markings/Labelling Problem 256 256
Unintended Movement 234 234
Positioning Failure 233 233
Device Slipped 231 231
Unintended Ejection 226 226
Fluid/Blood Leak 226 226
Failure to Power Up 223 223
Delivered as Unsterile Product 198 198
Appropriate Term/Code Not Available 186 186
Positioning Problem 172 172
Product Quality Problem 163 163
Difficult to Insert 160 160
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 148 148
Nonstandard Device 146 146
Device Misassembled During Manufacturing /Shipping 146 146
Defective Device 141 141
Failure to Read Input Signal 128 128
Unintended System Motion 128 128
Failure to Eject 112 112
Leak/Splash 111 111
Computer Software Problem 104 104
Separation Problem 102 102
Material Separation 99 99
Component Missing 98 98
No Display/Image 94 94
Manufacturing, Packaging or Shipping Problem 91 91
Electrical /Electronic Property Problem 83 83
Failure to Cycle 82 82
Material Protrusion/Extrusion 80 80
Difficult or Delayed Activation 75 75
Therapeutic or Diagnostic Output Failure 71 71
Overheating of Device 70 70
Structural Problem 67 67
Use of Device Problem 67 67
Separation Failure 66 66
Premature End-of-Life Indicator 66 66
No Device Output 62 62
Failure to Advance 62 62
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Material Fragmentation 58 58
Battery Problem 57 57
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 46 46
Loose or Intermittent Connection 44 44
Output Problem 43 43
Patient-Device Incompatibility 41 41
Display or Visual Feedback Problem 40 40
Material Split, Cut or Torn 38 38
Defective Component 37 37
Application Program Version or Upgrade Problem 36 36
Calibration Problem 34 34
Difficult to Advance 33 33
Device Remains Activated 33 33
Packaging Problem 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34850 34850
No Consequences Or Impact To Patient 18059 18059
No Code Available 4579 4580
Unspecified Tissue Injury 4453 4453
Insufficient Information 4369 4369
Failure to Anastomose 3444 3444
Hemorrhage/Bleeding 2828 2828
No Known Impact Or Consequence To Patient 2249 2249
Tissue Damage 1343 1343
No Information 1176 1176
Blood Loss 963 964
No Patient Involvement 921 921
Tissue Breakdown 906 906
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 502 502
Pain 498 498
Fistula 448 448
Unspecified Infection 337 337
Abscess 311 311
Hematoma 270 270
Foreign Body In Patient 269 269
Abdominal Pain 246 246
Sepsis 244 244
Fever 231 231
Laceration(s) 228 228
Obstruction/Occlusion 216 216
Injury 171 171
Unintended Radiation Exposure 167 167
Death 160 161
Peritonitis 153 153
Hernia 152 152
Inflammation 143 143
Wound Dehiscence 118 118
Vomiting 112 112
Seroma 108 108
Pneumothorax 103 103
Post Operative Wound Infection 103 103
Radiation Exposure, Unintended 99 99
Not Applicable 98 98
Tachycardia 94 94
Nausea 90 90
Pleural Effusion 83 83
Septic Shock 80 80
Pneumonia 76 76
Adhesion(s) 76 76
Low Blood Pressure/ Hypotension 72 72
Bowel Perforation 71 71
Device Embedded In Tissue or Plaque 70 70
Necrosis 67 67
Stenosis 64 64
Anemia 62 62
Perforation 56 56
Diarrhea 55 55
Pulmonary Emphysema 54 54
Impaired Healing 54 54
Incontinence 53 53
Fluid Discharge 52 52
Urinary Tract Infection 51 51
Abdominal Distention 49 49
Ulcer 44 44
High Blood Pressure/ Hypertension 43 43
Ischemia 42 42
Thrombosis/Thrombus 41 41
Urinary Retention 40 40
Cardiac Arrest 40 40
Bacterial Infection 39 39
Dyspnea 36 36
Renal Failure 36 36
Thrombosis 35 35
Swelling/ Edema 35 35
Purulent Discharge 34 34
Pulmonary Embolism 33 33
Ascites 32 32
Discomfort 32 32
Respiratory Failure 31 31
Perforation of Vessels 30 30
Exsanguination 29 29
Distress 29 29
Unspecified Respiratory Problem 29 29
Rectal Anastomotic Leakage 27 27
Organ Dehiscence 27 27
Dehydration 23 23
Failure of Implant 23 23
Shock 22 22
Myocardial Infarction 21 21
Emotional Changes 19 19
Swelling 18 18
Scar Tissue 16 16
Hypoxia 16 16
Chest Pain 16 16
Dysphagia/ Odynophagia 15 15
Itching Sensation 15 15
Muscle Weakness 15 15
Fibrosis 15 15
Anxiety 14 14
Hypersensitivity/Allergic reaction 14 14
Ecchymosis 13 13
Chills 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 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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