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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, implantable
Regulation Description Implantable staple.
Product CodeGDW
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD INC,
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU KANGDI MEDICAL STAPLER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING QMI SURGICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 12
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
DEXTERA SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 7
EZISURG (SUZHOU) MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GOLDEN STAPLER SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
REACH SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHINEMED LLC
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TGS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THD LAP
  SUBSTANTIALLY EQUIVALENT 1
VIA SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
VICTOR MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIEWPOINT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5103 5103
2017 11641 11641
2018 14912 14912
2019 16597 16597
2020 12351 12351
2021 9642 9642

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 24824 24824
Failure to Form Staple 12057 12057
Misfire 7231 7231
Difficult to Open or Close 5870 5870
Adverse Event Without Identified Device or Use Problem 4731 4731
Break 3593 3593
Human-Device Interface Problem 2406 2406
Entrapment of Device 2306 2306
Noise, Audible 2100 2100
Detachment of Device or Device Component 1982 1982
Mechanical Jam 1494 1494
Firing Problem 1356 1356
Mechanics Altered 1245 1245
Device Operates Differently Than Expected 1211 1211
Failure to Cut 1127 1127
Detachment Of Device Component 1048 1048
Difficult to Remove 923 923
Retraction Problem 891 891
Device Displays Incorrect Message 823 823
Loss of or Failure to Bond 804 804
Failure to Charge 760 760
Mechanical Problem 738 738
Complete Loss of Power 724 724
Failure To Adhere Or Bond 648 648
Insufficient Information 620 620
Component or Accessory Incompatibility 617 617
Fluid Leak 535 535
Power Problem 503 503
Expulsion 443 443
Device Difficult to Setup or Prepare 375 375
Difficult or Delayed Positioning 364 364
Physical Resistance/Sticking 351 351
Positioning Failure 342 342
Failure to Cycle 320 320
Device Inoperable 320 320
Material Twisted/Bent 304 304
Leak/Splash 301 301
Unintended Movement 279 279
Positioning Problem 247 247
Appropriate Term/Code Not Available 240 240
Activation, Positioning or SeparationProblem 233 233
Ejection Problem 232 232
Failure to Align 223 223
Material Integrity Problem 217 217
No Apparent Adverse Event 214 214
Device Slipped 214 214
Bent 211 211
Gas Leak 207 207
Corroded 206 206
Defective Device 201 201
Failure to Advance 193 193
Sticking 179 179
Activation Problem 167 167
Activation Failure 161 161
Patient Device Interaction Problem 147 147
Nonstandard Device 145 145
Component Missing 144 144
Loose or Intermittent Connection 138 138
Component Falling 121 121
Failure to Read Input Signal 121 121
Material Deformation 120 120
Physical Resistance 120 120
Air Leak 112 112
Unintended System Motion 109 109
Difficult to Insert 109 109
Product Quality Problem 106 106
Material Protrusion/Extrusion 99 99
Material Separation 98 98
Overheating of Device 96 96
Failure to Sense 92 92
Battery Problem 89 89
Fail-Safe Problem 86 86
Unintended Ejection 86 86
Separation Failure 82 82
Fitting Problem 79 79
No Display/Image 78 78
Defective Component 77 77
Difficult to Advance 77 77
Device Misassembled During Manufacturing /Shipping 77 77
Difficult To Position 75 75
Incorrect, Inadequate or Imprecise Resultor Readings 72 72
Device Fell 72 72
Delivered as Unsterile Product 69 69
Therapeutic or Diagnostic Output Failure 69 69
Device Stops Intermittently 68 68
Device Contamination with Chemical or Other Material 66 66
Difficult or Delayed Activation 65 65
Device Markings/Labelling Problem 61 61
Partial Blockage 61 61
Device Dislodged or Dislocated 58 58
Failure to Power Up 58 58
Crack 57 57
Tear, Rip or Hole in Device Packaging 57 57
Use of Device Problem 56 56
Self-Activation or Keying 55 55
Packaging Problem 54 54
Premature End-of-Life Indicator 51 51
Calibration Problem 50 50
Unintended Arm Motion 48 48
Patient-Device Incompatibility 47 47

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 27215 27215
No Known Impact Or Consequence To Patient 19306 19306
No Clinical Signs, Symptoms or Conditions 9240 9240
No Code Available 8847 8848
Tissue Damage 2778 2778
Blood Loss 2097 2099
Failure to Anastomose 2008 2008
No Information 1484 1484
No Patient Involvement 1317 1317
Unspecified Tissue Injury 1136 1136
Insufficient Information 930 930
Injury 830 830
Hemorrhage/Bleeding 825 825
Fistula 377 377
Pain 351 351
Death 314 316
Unspecified Infection 236 236
Hematoma 203 203
Abscess 199 199
Sepsis 179 179
Radiation Exposure, Unintended 167 167
Not Applicable 163 163
Foreign Body In Patient 159 159
Wound Dehiscence 152 152
Fever 133 133
Abdominal Pain 131 131
Obstruction/Occlusion 120 120
Peritonitis 116 116
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 107 107
Post Operative Wound Infection 91 91
Inflammation 70 70
Hernia 66 66
Incontinence 62 62
Vomiting 61 61
Device Embedded In Tissue or Plaque 56 56
Bowel Perforation 53 53
Exsanguination 52 52
Unintended Radiation Exposure 50 50
Tachycardia 49 49
Seroma 40 40
Thrombosis 40 40
Septic Shock 37 37
Adhesion(s) 37 37
Pneumonia 36 36
Necrosis 35 35
Stenosis 35 35
Pleural Effusion 33 33
Perforation 33 33
Low Blood Pressure/ Hypotension 33 33
Nausea 30 30
Laceration(s) 28 28
Cardiac Arrest 28 28
Anemia 28 28
Ischemia 27 27
Urinary Retention 27 27
Pulmonary Emphysema 25 25
Pneumothorax 24 24
Organ Dehiscence 21 21
Swelling 20 20
Shock 17 17
Dyspnea 16 16
Abdominal Distention 16 16
Fluid Discharge 15 15
High Blood Pressure/ Hypertension 15 15
Ulcer 14 14
Itching Sensation 14 14
Hemostasis 13 13
Edema 13 13
Urinary Tract Infection 13 13
Discomfort 13 13
Patient Problem/Medical Problem 12 12
Reaction 12 12
Renal Failure 11 11
Failure of Implant 11 11
Pulmonary Embolism 11 11
Scar Tissue 10 10
Scarring 10 10
Internal Organ Perforation 9 9
Distress 9 9
Purulent Discharge 9 9
Chest Pain 9 9
Impaired Healing 9 9
Cancer 9 9
Skin Tears 8 8
Hypovolemic Shock 8 8
Non-union Bone Fracture 8 8
Disability 8 8
Ascites 7 7
Bacterial Infection 7 7
Complaint, Ill-Defined 7 7
Myocardial Infarction 7 7
Respiratory Failure 7 7
Prolapse 6 6
Rectal Anastomotic Leakage 6 6
Unspecified Gastrointestinal Problem 6 6
Respiratory Distress 6 6
Diarrhea 6 6
Granuloma 6 6
Swelling/ Edema 6 6
Tissue Breakdown 5 5

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 Apr-09-2021
12 Covidien, LP II Oct-01-2020
13 Ethicon Endo-Surgery Inc II Aug-19-2021
14 Ethicon Endo-Surgery Inc I Oct-29-2019
15 Ethicon Endo-Surgery Inc I May-15-2019
16 Ethicon Endo-Surgery Inc II Jan-08-2019
17 Ethicon Endo-Surgery Inc II Feb-21-2018
18 Ethicon Endo-Surgery Inc II May-31-2017
19 Ethicon Endo-Surgery Inc II Oct-20-2016
20 Incisive Surgical Inc II Oct-05-2018
21 Intuitive Surgical, Inc. II Jul-06-2018
22 Medtronic II Feb-18-2016
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