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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 2
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL INC.
  SE - WITH LIMITATIONS 1
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 7
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 7
  SUBSTANTIALLY EQUIVALENT 29
TRANSENTERIX INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2017 1049 1049
2018 1074 1074
2019 1154 1154
2020 1558 1558
2021 1997 1997
2022 3474 3474

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2171 2171
Detachment of Device or Device Component 1646 1646
Adverse Event Without Identified Device or Use Problem 744 744
Failure to Deliver Energy 604 604
Material Split, Cut or Torn 583 583
Device Displays Incorrect Message 545 545
Difficult to Open or Close 534 534
Visual Prompts will not Clear 481 481
Arcing 429 429
Thermal Decomposition of Device 320 320
Insufficient Information 310 310
Defective Component 293 293
Detachment Of Device Component 276 276
Material Fragmentation 247 247
Device Operates Differently Than Expected 232 232
No Device Output 163 163
Defective Device 148 148
Unintended System Motion 146 146
Output Problem 136 136
No Display/Image 120 120
Device Dislodged or Dislocated 109 109
Electrical /Electronic Property Problem 103 103
Material Separation 101 101
Difficult to Remove 83 83
Device Or Device Fragments Location Unknown 82 82
Mechanical Problem 76 76
Material Frayed 71 71
Physical Resistance/Sticking 70 70
Energy Output Problem 67 67
Scratched Material 66 66
Melted 61 61
Failure to Cut 58 58
Poor Quality Image 50 50
Unintended Movement 48 48
Therapeutic or Diagnostic Output Failure 47 47
Failure to Fire 47 47
Entrapment of Device 39 39
Use of Device Problem 38 38
Misfire 37 37
Failure to Form Staple 37 37
Retraction Problem 36 36
Appropriate Term/Code Not Available 36 36
Mechanical Jam 36 36
Smoking 34 34
Failure to Sense 33 33
Material Protrusion/Extrusion 32 32
Power Problem 31 31
Crack 31 31
Material Twisted/Bent 30 30
No Apparent Adverse Event 28 28
Fracture 28 28
Component Missing 28 28
Sparking 27 27
Device Issue 26 26
Material Integrity Problem 24 24
Dull, Blunt 23 23
Loose or Intermittent Connection 22 22
Failure to Power Up 21 21
Display or Visual Feedback Problem 21 21
Positioning Failure 19 19
Device Inoperable 19 19
Loss of or Failure to Bond 17 17
Firing Problem 17 17
Device Fell 16 16
Component Falling 16 16
Failure to Calibrate 16 16
Device Slipped 15 15
Noise, Audible 14 14
Unexpected Shutdown 14 14
Failure to Align 13 13
Image Orientation Incorrect 13 13
Degraded 11 11
Mechanics Altered 11 11
Optical Problem 10 10
Material Deformation 10 10
Bent 10 10
Loss of Power 10 10
Grounding Malfunction 9 9
Battery Problem 9 9
Positioning Problem 9 9
Activation Problem 8 8
Blocked Connection 8 8
Connection Problem 8 8
Device Sensing Problem 8 8
Failure to Advance 8 8
Improper or Incorrect Procedure or Method 8 8
Sticking 7 7
Activation, Positioning or SeparationProblem 7 7
Device Alarm System 7 7
Misfocusing 7 7
Activation Failure 7 7
Protective Measures Problem 7 7
Patient Device Interaction Problem 6 6
Human-Device Interface Problem 6 6
Computer Software Problem 6 6
Energy Output To Patient Tissue Incorrect 6 6
Difficult or Delayed Activation 6 6
Calibration Problem 5 5
Malposition of Device 5 5
Material Discolored 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3982 3982
No Known Impact Or Consequence To Patient 3383 3383
Device Embedded In Tissue or Plaque 557 557
Insufficient Information 537 537
Hemorrhage/Bleeding 426 426
Foreign Body In Patient 287 287
Unspecified Tissue Injury 228 228
Blood Loss 178 178
Injury 160 160
No Consequences Or Impact To Patient 121 121
No Information 93 93
Death 82 82
Burn(s) 78 78
Unspecified Infection 55 55
Tissue Damage 53 53
Bowel Perforation 44 44
Failure to Anastomose 44 44
Pain 43 43
Hematoma 41 41
Perforation of Vessels 41 41
No Patient Involvement 36 36
Bowel Burn 34 34
Burn, Thermal 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Sepsis 28 28
No Code Available 24 24
Fistula 20 20
Laceration(s) 18 18
Hernia 17 17
Unspecified Vascular Problem 16 16
Abdominal Pain 15 15
Abscess 14 14
Perforation 14 14
Nerve Damage 13 13
Obstruction/Occlusion 13 13
Internal Organ Perforation 11 11
Cardiac Arrest 11 11
Adhesion(s) 10 10
Pneumonia 9 9
Great Vessel Perforation 9 9
Low Blood Pressure/ Hypotension 8 8
Bruise/Contusion 8 8
Fever 8 8
Anemia 7 7
Thrombosis/Thrombus 7 7
Heart Failure/Congestive Heart Failure 6 6
Pulmonary Embolism 6 6
Stroke/CVA 6 6
Liver Laceration(s) 6 6
Ischemia 6 6
Necrosis 6 6
Urinary Tract Infection 6 6
Post Operative Wound Infection 6 6
Pseudoaneurysm 6 6
Renal Failure 5 5
Seroma 5 5
Atrial Fibrillation 5 5
Wound Dehiscence 5 5
Unspecified Gastrointestinal Problem 5 5
Swelling/ Edema 5 5
Rectal Anastomotic Leakage 4 4
Vascular Dissection 4 4
Arrhythmia 4 4
Bacterial Infection 4 4
Pneumothorax 4 4
Myocardial Infarction 4 4
Cancer 4 4
Fluid Discharge 4 4
Pleural Effusion 4 4
Swelling 4 4
Respiratory Tract Infection 3 3
Numbness 3 3
Discomfort 3 3
Peritonitis 3 3
Full thickness (Third Degree) Burn 3 3
Liver Damage/Dysfunction 3 3
Incontinence 3 3
Septic Shock 3 3
Aspiration/Inhalation 3 3
Unspecified Kidney or Urinary Problem 3 3
Muscle/Tendon Damage 3 3
Unspecified Musculoskeletal problem 2 2
Skin Infection 2 2
Respiratory Arrest 2 2
Hyponatremia 2 2
Renal Impairment 2 2
Embolism 2 2
Dehydration 2 2
Purulent Discharge 2 2
Bone Fracture(s) 2 2
Exsanguination 2 2
Hemothorax 2 2
Hypoxia 2 2
Infiltration into Tissue 2 2
Inflammation 2 2
Superficial (First Degree) Burn 2 2
Multiple Organ Failure 2 2
Unspecified Blood or Lymphatic problem 2 2
Diminished Pulse Pressure 2 2
Hematuria 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Intuitive Surgical Inc II May-05-2020
2 Intuitive Surgical, Inc. II Aug-01-2022
3 Intuitive Surgical, Inc. II Jul-25-2022
4 Intuitive Surgical, Inc. II May-31-2022
5 Intuitive Surgical, Inc. II Apr-22-2022
6 Intuitive Surgical, Inc. II Mar-01-2022
7 Intuitive Surgical, Inc. II Dec-27-2021
8 Intuitive Surgical, Inc. II Nov-23-2021
9 Intuitive Surgical, Inc. II Oct-23-2020
10 Intuitive Surgical, Inc. II Jun-03-2020
11 Intuitive Surgical, Inc. II Jun-01-2020
12 Intuitive Surgical, Inc. II May-11-2020
13 Intuitive Surgical, Inc. II May-06-2020
14 Intuitive Surgical, Inc. II Feb-06-2020
15 Intuitive Surgical, Inc. II Jan-31-2020
16 Intuitive Surgical, Inc. II Jan-24-2020
17 Intuitive Surgical, Inc. II Oct-30-2019
18 Intuitive Surgical, Inc. II Feb-15-2019
19 Intuitive Surgical, Inc. II Sep-26-2018
20 Intuitive Surgical, Inc. II Sep-12-2018
21 Intuitive Surgical, Inc. II Aug-16-2018
22 Intuitive Surgical, Inc. II Jul-02-2018
23 Intuitive Surgical, Inc. II Jan-23-2018
24 Intuitive Surgical, Inc. II Jun-06-2017
25 Intuitive Surgical, Inc. II Apr-13-2017
26 Intuitive Surgical, Inc. II Apr-05-2017
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