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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 11222 11222

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 29428 29428
Failure to Form Staple 13326 13326
Misfire 8525 8525
Difficult to Open or Close 6820 6820
Adverse Event Without Identified Device or Use Problem 6327 6327
Break 4023 4023
Entrapment of Device 2829 2829
Human-Device Interface Problem 2825 2825
Detachment of Device or Device Component 2591 2591
Noise, Audible 2378 2378
Mechanical Jam 1544 1544
Firing Problem 1463 1463
Mechanics Altered 1419 1419
Failure to Cut 1396 1396
Insufficient Information 1383 1383
Complete Loss of Power 1173 1173
Failure to Charge 1084 1084
Device Displays Incorrect Message 1025 1025
Difficult to Remove 974 974
Loss of or Failure to Bond 963 963
Detachment Of Device Component 937 937
Retraction Problem 868 868
Component or Accessory Incompatibility 789 789
Mechanical Problem 690 690
Device Operates Differently Than Expected 677 677
Power Problem 533 533
Expulsion 519 519
Fluid/Blood Leak 501 501
Failure To Adhere Or Bond 479 479
Difficult or Delayed Positioning 463 463
No Apparent Adverse Event 449 449
Ejection Problem 442 442
Material Integrity Problem 398 398
Device Difficult to Setup or Prepare 393 393
Patient Device Interaction Problem 389 389
Physical Resistance/Sticking 385 385
Material Twisted/Bent 371 371
Unintended Movement 312 312
Activation Failure 308 308
Corroded 301 301
Positioning Problem 272 272
Failure to Align 263 263
Device Inoperable 247 247
Appropriate Term/Code Not Available 244 244
Positioning Failure 240 240
Leak/Splash 235 235
Device Slipped 230 230
Activation Problem 222 222
Activation, Positioning or Separation Problem 217 217
Defective Device 207 207
Gas/Air Leak 207 207
Failure to Power Up 201 201
Bent 155 155
Failure to Advance 153 153
Nonstandard Device 147 147
Product Quality Problem 144 144
Failure to Read Input Signal 141 141
Component Missing 138 138
Unintended Ejection 134 134
Difficult to Insert 125 125
Unintended System Motion 118 118
Delivered as Unsterile Product 115 115
Physical Resistance 114 114
Loose or Intermittent Connection 106 106
Sticking 99 99
Device Misassembled During Manufacturing /Shipping 99 99
Material Protrusion/Extrusion 98 98
Fail-Safe Problem 97 97
Overheating of Device 97 97
Self-Activation or Keying 96 96
Failure to Cycle 96 96
Material Separation 93 93
Material Deformation 92 92
No Display/Image 89 89
Separation Failure 86 86
Failure to Sense 85 85
Air Leak 83 83
Failure to Eject 81 81
Battery Problem 80 80
Difficult to Advance 80 80
Device Markings/Labelling Problem 79 79
Therapeutic or Diagnostic Output Failure 74 74
Device Fell 72 72
Use of Device Problem 72 72
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Electrical /Electronic Property Problem 68 68
Defective Component 68 68
Component Falling 65 65
Difficult or Delayed Activation 65 65
Manufacturing, Packaging or Shipping Problem 63 63
Fitting Problem 63 63
Difficult To Position 62 62
Premature End-of-Life Indicator 62 62
Device Contamination with Chemical or Other Material 61 61
Patient-Device Incompatibility 55 55
Tear, Rip or Hole in Device Packaging 55 55
Protective Measures Problem 54 54
Material Fragmentation 53 53
Calibration Problem 51 51
Separation Problem 49 49

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 19845 19845
No Known Impact Or Consequence To Patient 18432 18432
No Code Available 8204 8205
Unspecified Tissue Injury 2845 2845
Failure to Anastomose 2666 2666
Insufficient Information 2591 2591
Tissue Damage 2577 2577
Blood Loss 1766 1768
Hemorrhage/Bleeding 1654 1654
No Information 1421 1421
No Patient Involvement 1302 1302
Injury 476 476
Pain 425 425
Fistula 422 422
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 346 346
Unspecified Infection 295 295
Death 277 279
Abscess 272 272
Hematoma 249 249
Sepsis 229 229
Abdominal Pain 203 203
Foreign Body In Patient 202 202
Fever 196 196
Obstruction/Occlusion 188 188
Radiation Exposure, Unintended 163 163
Not Applicable 159 159
Wound Dehiscence 152 152
Peritonitis 142 142
Post Operative Wound Infection 118 118
Unintended Radiation Exposure 117 117
Hernia 110 110
Inflammation 109 109
Vomiting 97 97
Tachycardia 80 80
Seroma 75 75
Nausea 70 70
Bowel Perforation 67 67
Device Embedded In Tissue or Plaque 65 65
Incontinence 65 65
Septic Shock 64 64
Pleural Effusion 62 62
Necrosis 61 61
Low Blood Pressure/ Hypotension 58 58
Adhesion(s) 58 58
Stenosis 58 58
Exsanguination 55 55
Laceration(s) 52 52
Perforation 52 52
Pneumonia 50 50
Anemia 43 43
Pneumothorax 41 41
Thrombosis 40 40
Urinary Retention 35 35
Cardiac Arrest 35 35
Ulcer 35 35
Fluid Discharge 33 33
Abdominal Distention 33 33
Impaired Healing 32 32
Ischemia 31 31
High Blood Pressure/ Hypertension 31 31
Urinary Tract Infection 30 30
Renal Failure 30 30
Respiratory Failure 28 28
Diarrhea 27 27
Dyspnea 26 26
Pulmonary Emphysema 26 26
Purulent Discharge 25 25
Bacterial Infection 23 23
Pulmonary Embolism 22 22
Shock 22 22
Thrombosis/Thrombus 20 20
Discomfort 19 19
Swelling 19 19
Organ Dehiscence 18 18
Ascites 18 18
Swelling/ Edema 17 17
Failure of Implant 17 17
Scar Tissue 15 15
Itching Sensation 14 14
Dehydration 14 14
Chest Pain 13 13
Hemostasis 13 13
Myocardial Infarction 13 13
Perforation of Vessels 13 13
Distress 13 13
Chills 12 12
Rectal Anastomotic Leakage 12 12
Cancer 12 12
Edema 12 12
Dysphagia/ Odynophagia 12 12
Granuloma 11 11
Muscle Weakness 11 11
Patient Problem/Medical Problem 11 11
Constipation 11 11
Anxiety 11 11
Reaction 11 11
Fibrosis 10 10
Syncope/Fainting 9 9
Cardiovascular Insufficiency 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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