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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, surgical, computer controlled instrument
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeNAY
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AKTORMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 3
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 15
  SE - WITH LIMITATIONS 9
TRANSENTERIX INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 1154 1154
2020 1558 1558
2021 1997 1997
2022 5728 5728
2023 10899 10899
2024 11670 11670

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4801 4801
Material Fragmentation 3455 3455
Break 3090 3090
Visual Prompts will not Clear 2976 2976
Difficult to Open or Close 2724 2724
Material Split, Cut or Torn 1827 1827
Thermal Decomposition of Device 1591 1591
Adverse Event Without Identified Device or Use Problem 1428 1428
Unintended System Motion 1419 1419
Output Problem 1333 1333
Failure to Deliver Energy 1099 1099
No Device Output 748 748
Arcing 715 715
Energy Output Problem 554 554
No Apparent Adverse Event 470 470
Unintended Movement 447 447
Insufficient Information 424 424
No Display/Image 410 410
Difficult to Remove 386 386
Material Integrity Problem 362 362
Physical Resistance/Sticking 287 287
Defective Device 279 279
Material Separation 277 277
Material Frayed 263 263
Device Displays Incorrect Message 258 258
Entrapment of Device 251 251
Image Orientation Incorrect 241 241
Defective Component 232 232
Device Dislodged or Dislocated 219 219
Failure to Sense 211 211
Appropriate Term/Code Not Available 154 154
Power Problem 136 136
Mechanical Problem 133 133
Positioning Failure 113 113
Failure to Cut 110 110
Material Twisted/Bent 109 109
Fracture 91 91
Melted 87 87
Failure to Fire 86 86
Positioning Problem 86 86
Scratched Material 86 86
Crack 81 81
Poor Quality Image 79 79
Display or Visual Feedback Problem 73 73
Firing Problem 72 72
Grounding Malfunction 71 71
Smoking 65 65
Sparking 64 64
Failure to Form Staple 63 63
Failure to Power Up 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24302 24302
Insufficient Information 2466 2466
No Known Impact Or Consequence To Patient 2006 2006
Foreign Body In Patient 1598 1598
Hemorrhage/Bleeding 906 906
Unspecified Tissue Injury 742 742
Device Embedded In Tissue or Plaque 326 326
Burn(s) 145 145
Blood Loss 108 108
Injury 106 106
Bowel Perforation 83 83
Perforation of Vessels 70 70
Unspecified Infection 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
Hematoma 64 64
Death 55 55
No Consequences Or Impact To Patient 52 52
Failure to Anastomose 50 50
Pain 49 49
Sepsis 49 49
Cardiac Arrest 46 46
Fistula 42 42
Laceration(s) 37 37
Hernia 35 35
Bowel Burn 34 34
Great Vessel Perforation 30 30
Bacterial Infection 30 30
Obstruction/Occlusion 26 26
Abscess 26 26
Seroma 22 22
Pulmonary Embolism 22 22
Burn, Thermal 21 21
Abdominal Pain 21 21
Tissue Damage 20 20
Pneumothorax 20 20
No Patient Involvement 19 19
Pneumonia 19 19
Thrombosis/Thrombus 19 19
Rectal Anastomotic Leakage 19 19
Low Blood Pressure/ Hypotension 18 18
Post Operative Wound Infection 18 18
Unspecified Vascular Problem 18 18
Myocardial Infarction 16 16
Perforation 15 15
Ischemia 14 14
Fever 14 14
Bruise/Contusion 14 14
No Information 13 13
Nerve Damage 13 13
Urinary Tract Infection 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Asensus Surgical Inc I Oct-30-2023
2 Intuitive Surgical Inc II May-05-2020
3 Intuitive Surgical, Inc. II Apr-11-2024
4 Intuitive Surgical, Inc. II Nov-28-2023
5 Intuitive Surgical, Inc. II Jun-30-2023
6 Intuitive Surgical, Inc. II Mar-28-2023
7 Intuitive Surgical, Inc. II Mar-16-2023
8 Intuitive Surgical, Inc. II Nov-30-2022
9 Intuitive Surgical, Inc. II Oct-25-2022
10 Intuitive Surgical, Inc. II Aug-01-2022
11 Intuitive Surgical, Inc. II Jul-25-2022
12 Intuitive Surgical, Inc. II May-31-2022
13 Intuitive Surgical, Inc. II Apr-22-2022
14 Intuitive Surgical, Inc. II Mar-01-2022
15 Intuitive Surgical, Inc. II Dec-27-2021
16 Intuitive Surgical, Inc. II Nov-23-2021
17 Intuitive Surgical, Inc. II Oct-23-2020
18 Intuitive Surgical, Inc. II Jun-03-2020
19 Intuitive Surgical, Inc. II Jun-01-2020
20 Intuitive Surgical, Inc. II May-11-2020
21 Intuitive Surgical, Inc. II May-06-2020
22 Intuitive Surgical, Inc. II Feb-06-2020
23 Intuitive Surgical, Inc. II Jan-31-2020
24 Intuitive Surgical, Inc. II Jan-24-2020
25 Intuitive Surgical, Inc. II Oct-30-2019
26 Intuitive Surgical, Inc. II Feb-15-2019
27 Olympus Corporation of the Americas II Jun-28-2024
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