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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device staple, implantable
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 1
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU KANGDI MEDICAL STAPLER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING QMI SURGICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 17
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 6
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 2
REACH SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TGS MEDICAL CO., LTD.
  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
2017 11641 11641
2018 14912 14912
2019 16597 16597
2020 12351 12351
2021 13047 13047
2022 12377 12377

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 29825 29825
Failure to Form Staple 13525 13525
Misfire 8691 8691
Difficult to Open or Close 6915 6915
Adverse Event Without Identified Device or Use Problem 6497 6497
Break 4089 4089
Human-Device Interface Problem 2870 2870
Entrapment of Device 2867 2867
Detachment of Device or Device Component 2634 2634
Noise, Audible 2410 2410
Mechanical Jam 1560 1560
Firing Problem 1485 1485
Insufficient Information 1454 1454
Mechanics Altered 1440 1440
Failure to Cut 1422 1422
Complete Loss of Power 1192 1192
Failure to Charge 1097 1097
Device Displays Incorrect Message 1035 1035
Difficult to Remove 981 981
Loss of or Failure to Bond 978 978
Detachment Of Device Component 937 937
Retraction Problem 871 871
Component or Accessory Incompatibility 797 797
Mechanical Problem 692 692
Device Operates Differently Than Expected 677 677
Power Problem 533 533
Expulsion 524 524
Fluid/Blood Leak 501 501
Failure To Adhere Or Bond 479 479
No Apparent Adverse Event 467 467
Difficult or Delayed Positioning 467 467
Ejection Problem 459 459
Material Integrity Problem 426 426
Patient Device Interaction Problem 401 401
Device Difficult to Setup or Prepare 398 398
Physical Resistance/Sticking 387 387
Material Twisted/Bent 378 378
Unintended Movement 314 314
Activation Failure 314 314
Corroded 303 303
Positioning Problem 274 274
Failure to Align 270 270
Device Inoperable 247 247
Appropriate Term/Code Not Available 246 246
Positioning Failure 243 243
Device Slipped 236 236
Leak/Splash 235 235
Activation Problem 227 227
Activation, Positioning or Separation Problem 218 218
Defective Device 207 207
Gas/Air Leak 207 207
Failure to Power Up 205 205
Bent 155 155
Failure to Advance 153 153
Nonstandard Device 147 147
Product Quality Problem 145 145
Failure to Read Input Signal 142 142
Component Missing 142 142
Difficult to Insert 138 138
Unintended Ejection 136 136
Unintended System Motion 126 126
Delivered as Unsterile Product 122 122
Physical Resistance 114 114
Loose or Intermittent Connection 106 106
Device Misassembled During Manufacturing /Shipping 102 102
Sticking 99 99
Fail-Safe Problem 99 99
Self-Activation or Keying 98 98
Material Protrusion/Extrusion 98 98
Overheating of Device 97 97
Failure to Cycle 96 96
Material Separation 95 95
Material Deformation 93 93
No Display/Image 89 89
Separation Failure 87 87
Failure to Sense 86 86
Device Markings/Labelling Problem 84 84
Air Leak 83 83
Failure to Eject 82 82
Difficult to Advance 80 80
Battery Problem 80 80
Therapeutic or Diagnostic Output Failure 74 74
Use of Device Problem 72 72
Device Fell 72 72
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Electrical /Electronic Property Problem 68 68
Defective Component 68 68
Difficult or Delayed Activation 67 67
Component Falling 65 65
Manufacturing, Packaging or Shipping Problem 64 64
Fitting Problem 63 63
Premature End-of-Life Indicator 62 62
Difficult To Position 62 62
Device Contamination with Chemical or Other Material 61 61
Material Fragmentation 56 56
Protective Measures Problem 56 56
Patient-Device Incompatibility 55 55
Tear, Rip or Hole in Device Packaging 55 55
Calibration Problem 51 51
Separation Problem 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 24318 24318
No Clinical Signs, Symptoms or Conditions 20694 20694
No Known Impact Or Consequence To Patient 18432 18432
No Code Available 8204 8205
Unspecified Tissue Injury 2994 2994
Failure to Anastomose 2711 2711
Insufficient Information 2695 2695
Tissue Damage 2577 2577
Blood Loss 1766 1768
Hemorrhage/Bleeding 1716 1716
No Information 1421 1421
No Patient Involvement 1302 1302
Injury 476 476
Pain 436 436
Fistula 429 429
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 360 360
Unspecified Infection 308 308
Death 277 279
Abscess 276 276
Hematoma 252 252
Sepsis 237 237
Abdominal Pain 209 209
Foreign Body In Patient 207 207
Fever 202 202
Obstruction/Occlusion 196 196
Radiation Exposure, Unintended 163 163
Not Applicable 159 159
Wound Dehiscence 153 153
Peritonitis 143 143
Post Operative Wound Infection 121 121
Hernia 120 120
Unintended Radiation Exposure 119 119
Inflammation 111 111
Vomiting 104 104
Tachycardia 85 85
Seroma 81 81
Nausea 72 72
Bowel Perforation 68 68
Pleural Effusion 66 66
Device Embedded In Tissue or Plaque 66 66
Incontinence 65 65
Septic Shock 64 64
Necrosis 64 64
Low Blood Pressure/ Hypotension 59 59
Adhesion(s) 58 58
Stenosis 58 58
Pneumonia 57 57
Exsanguination 55 55
Laceration(s) 53 53
Perforation 52 52
Anemia 45 45
Pneumothorax 42 42
Thrombosis 40 40
Urinary Retention 38 38
Cardiac Arrest 37 37
Impaired Healing 37 37
Ulcer 36 36
Abdominal Distention 35 35
Fluid Discharge 35 35
Urinary Tract Infection 32 32
High Blood Pressure/ Hypertension 32 32
Diarrhea 32 32
Ischemia 31 31
Renal Failure 31 31
Respiratory Failure 28 28
Dyspnea 26 26
Pulmonary Emphysema 26 26
Purulent Discharge 25 25
Pulmonary Embolism 24 24
Thrombosis/Thrombus 24 24
Shock 23 23
Bacterial Infection 23 23
Perforation of Vessels 21 21
Discomfort 19 19
Swelling 19 19
Organ Dehiscence 18 18
Swelling/ Edema 18 18
Ascites 18 18
Failure of Implant 17 17
Dehydration 16 16
Myocardial Infarction 15 15
Scar Tissue 15 15
Itching Sensation 14 14
Hemostasis 13 13
Chest Pain 13 13
Distress 13 13
Rectal Anastomotic Leakage 13 13
Dysphagia/ Odynophagia 12 12
Cancer 12 12
Anxiety 12 12
Edema 12 12
Chills 12 12
Patient Problem/Medical Problem 11 11
Constipation 11 11
Reaction 11 11
Fibrosis 11 11
Granuloma 11 11
Muscle Weakness 11 11
Hypoxia 10 10
Internal Organ Perforation 9 9

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 Incisive Surgical Inc II Oct-05-2018
20 Intuitive Surgical, Inc. II Jul-06-2018
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