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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 17
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 4
EZISURG (SUZHOU) MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEXINGTON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
LEXINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
VIEWPOINT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WUXI BEIEN SURGERY DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 14913 14913
2019 16597 16597
2020 12327 12327
2021 13015 13015
2022 13607 13607
2023 9815 9815

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 29449 29449
Failure to Form Staple 12866 12866
Misfire 8621 8621
Adverse Event Without Identified Device or Use Problem 7269 7269
Difficult to Open or Close 7025 7025
Break 4076 4076
Detachment of Device or Device Component 2966 2966
Entrapment of Device 2871 2871
Human-Device Interface Problem 2562 2562
Noise, Audible 2115 2115
Insufficient Information 1993 1993
Firing Problem 1662 1662
Mechanical Jam 1544 1544
Failure to Cut 1493 1493
Complete Loss of Power 1342 1342
Mechanics Altered 1292 1292
Failure to Charge 1191 1191
Loss of or Failure to Bond 1083 1083
Device Displays Incorrect Message 1055 1055
Component or Accessory Incompatibility 921 921
Difficult to Remove 854 854
No Apparent Adverse Event 800 800
Retraction Problem 787 787
Mechanical Problem 620 620
Ejection Problem 600 600
Material Integrity Problem 599 599
Power Problem 532 532
Patient Device Interaction Problem 532 532
Expulsion 518 518
Material Twisted/Bent 421 421
Physical Resistance/Sticking 420 420
Activation Failure 415 415
Difficult or Delayed Positioning 394 394
Fluid/Blood Leak 382 382
Device Difficult to Setup or Prepare 326 326
Corroded 321 321
Detachment Of Device Component 310 310
Activation Problem 304 304
Failure to Align 267 267
Unintended Movement 249 249
Device Markings/Labelling Problem 249 249
Device Slipped 240 240
Device Operates Differently Than Expected 239 239
Positioning Problem 236 236
Positioning Failure 228 228
Failure to Power Up 216 216
Appropriate Term/Code Not Available 214 214
Gas/Air Leak 206 206
Defective Device 203 203
Activation, Positioning or Separation Problem 192 192
Unintended Ejection 181 181
Failure To Adhere Or Bond 178 178
Leak/Splash 176 176
Delivered as Unsterile Product 168 168
Product Quality Problem 159 159
Tear, Rip or Hole in Device Packaging 156 156
Nonstandard Device 147 147
Difficult to Insert 140 140
Device Misassembled During Manufacturing /Shipping 136 136
Component Missing 127 127
Self-Activation or Keying 125 125
Unintended System Motion 125 125
Failure to Read Input Signal 124 124
Failure to Advance 117 117
Material Separation 102 102
No Display/Image 97 97
Failure to Eject 95 95
Material Protrusion/Extrusion 92 92
Overheating of Device 86 86
Device Inoperable 83 83
Loose or Intermittent Connection 82 82
Manufacturing, Packaging or Shipping Problem 81 81
Failure to Cycle 80 80
Electrical /Electronic Property Problem 77 77
Battery Problem 77 77
Separation Problem 76 76
Separation Failure 73 73
Device Fell 72 72
Therapeutic or Diagnostic Output Failure 72 72
Fail-Safe Problem 70 70
Use of Device Problem 70 70
Incorrect, Inadequate or Imprecise Result or Readings 67 67
Premature End-of-Life Indicator 65 65
Material Fragmentation 65 65
Material Deformation 65 65
Difficult to Advance 64 64
Difficult or Delayed Activation 63 63
Patient-Device Incompatibility 60 60
Structural Problem 59 59
Computer Software Problem 59 59
Bent 56 56
No Device Output 55 55
Device Contamination with Chemical or Other Material 55 55
Protective Measures Problem 55 55
Defective Component 53 53
Unraveled Material 48 48
Excessive Heating 48 48
Calibration Problem 45 45
Output Problem 44 44
Packaging Problem 42 42

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28676 28676
No Consequences Or Impact To Patient 21364 21364
No Known Impact Or Consequence To Patient 11569 11569
No Code Available 6722 6723
Unspecified Tissue Injury 4284 4284
Insufficient Information 3671 3671
Failure to Anastomose 3217 3217
Hemorrhage/Bleeding 2297 2297
Tissue Damage 1824 1824
Blood Loss 1392 1393
No Information 1329 1329
No Patient Involvement 1231 1231
Pain 496 496
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 451 451
Fistula 443 443
Unspecified Infection 351 351
Abscess 302 302
Sepsis 269 269
Hematoma 268 268
Foreign Body In Patient 263 263
Abdominal Pain 238 238
Fever 234 234
Death 228 229
Injury 228 228
Obstruction/Occlusion 225 225
Peritonitis 166 166
Tissue Breakdown 164 164
Hernia 157 157
Unintended Radiation Exposure 145 145
Radiation Exposure, Unintended 133 133
Inflammation 131 131
Not Applicable 129 129
Laceration(s) 126 126
Wound Dehiscence 121 121
Post Operative Wound Infection 119 119
Vomiting 115 115
Seroma 106 106
Tachycardia 98 98
Nausea 89 89
Pleural Effusion 87 87
Septic Shock 78 78
Low Blood Pressure/ Hypotension 75 75
Pneumothorax 74 74
Pneumonia 73 73
Adhesion(s) 72 72
Bowel Perforation 70 70
Incontinence 68 68
Device Embedded In Tissue or Plaque 67 67
Stenosis 65 65
Perforation 61 61
Anemia 60 60
Necrosis 58 58
Pulmonary Emphysema 55 55
Urinary Tract Infection 50 50
Impaired Healing 50 50
Diarrhea 49 49
Fluid Discharge 48 48
Abdominal Distention 46 46
Urinary Retention 46 46
Cardiac Arrest 44 44
Exsanguination 43 43
High Blood Pressure/ Hypertension 43 43
Thrombosis 39 39
Thrombosis/Thrombus 39 39
Ulcer 39 39
Renal Failure 38 38
Bacterial Infection 38 38
Dyspnea 37 37
Ischemia 37 37
Pulmonary Embolism 33 33
Respiratory Failure 31 31
Purulent Discharge 30 30
Perforation of Vessels 29 29
Unspecified Respiratory Problem 29 29
Swelling/ Edema 28 28
Ascites 27 27
Discomfort 26 26
Shock 25 25
Distress 22 22
Organ Dehiscence 22 22
Rectal Anastomotic Leakage 22 22
Failure of Implant 21 21
Dehydration 21 21
Myocardial Infarction 20 20
Swelling 19 19
Scar Tissue 16 16
Muscle Weakness 16 16
Hypoxia 16 16
Dysphagia/ Odynophagia 16 16
Fibrosis 16 16
Cancer 15 15
Itching Sensation 15 15
Chest Pain 14 14
Emotional Changes 13 13
Hemostasis 13 13
Internal Organ Perforation 13 13
Syncope/Fainting 13 13
Weight Changes 13 13
Chills 13 13
Anxiety 12 12

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Feb-18-2020
2 COVIDIEN MEDTRONIC II Jul-19-2018
3 COVIDIEN MEDTRONIC II May-16-2018
4 Covidien LLC II Jun-16-2019
5 Covidien LLC II Apr-26-2018
6 Covidien LLC II Mar-27-2018
7 Covidien LLC II Mar-06-2018
8 Covidien LLC II Feb-16-2018
9 Covidien Llc II Apr-13-2021
10 Covidien Llc II Dec-29-2020
11 Covidien, LP II Mar-06-2023
12 Covidien, LP II Apr-09-2021
13 Covidien, LP II Oct-01-2020
14 Ethicon Endo-Surgery Inc II Aug-19-2021
15 Ethicon Endo-Surgery Inc I Oct-29-2019
16 Ethicon Endo-Surgery Inc I May-15-2019
17 Ethicon Endo-Surgery Inc II Jan-08-2019
18 Ethicon Endo-Surgery Inc II Feb-21-2018
19 Incisive Surgical Inc II Oct-05-2018
20 Intuitive Surgical, Inc. II Jul-06-2018
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