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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
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 7
  SUBSTANTIALLY EQUIVALENT 17
TRANSENTERIX INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2018 1074 1074
2019 1154 1154
2020 1558 1558
2021 1997 1997
2022 5727 5727

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1934 1934
Break 1733 1733
Adverse Event Without Identified Device or Use Problem 849 849
Visual Prompts will not Clear 741 741
Difficult to Open or Close 684 684
Material Split, Cut or Torn 671 671
Failure to Deliver Energy 639 639
Arcing 440 440
Thermal Decomposition of Device 429 429
Device Displays Incorrect Message 400 400
Material Fragmentation 351 351
Unintended System Motion 331 331
Output Problem 293 293
Defective Component 276 276
Insufficient Information 270 270
No Device Output 245 245
Defective Device 190 190
No Display/Image 163 163
Difficult to Remove 120 120
Physical Resistance/Sticking 118 118
Material Separation 115 115
Device Dislodged or Dislocated 112 112
Material Frayed 108 108
Detachment Of Device Component 99 99
No Apparent Adverse Event 98 98
Energy Output Problem 95 95
Mechanical Problem 77 77
Device Operates Differently Than Expected 73 73
Failure to Sense 69 69
Scratched Material 65 65
Melted 61 61
Failure to Cut 58 58
Failure to Fire 58 58
Unintended Movement 58 58
Material Integrity Problem 57 57
Failure to Form Staple 52 52
Therapeutic or Diagnostic Output Failure 49 49
Poor Quality Image 47 47
Appropriate Term/Code Not Available 46 46
Entrapment of Device 45 45
Smoking 40 40
Use of Device Problem 40 40
Positioning Failure 39 39
Mechanical Jam 37 37
Material Twisted/Bent 36 36
Misfire 34 34
Electrical /Electronic Property Problem 33 33
Retraction Problem 33 33
Fracture 32 32
Crack 32 32
Sparking 30 30
Power Problem 30 30
Display or Visual Feedback Problem 28 28
Image Orientation Incorrect 28 28
Material Protrusion/Extrusion 27 27
Device Or Device Fragments Location Unknown 26 26
Firing Problem 25 25
Component Missing 24 24
Dull, Blunt 24 24
Failure to Calibrate 21 21
Loose or Intermittent Connection 20 20
Unexpected Shutdown 19 19
Activation Problem 18 18
Noise, Audible 18 18
Failure to Power Up 18 18
Loss of or Failure to Bond 17 17
Device Fell 17 17
Grounding Malfunction 16 16
Mechanics Altered 15 15
Failure to Align 14 14
Device Slipped 13 13
Activation Failure 13 13
Optical Problem 12 12
Connection Problem 10 10
Degraded 10 10
Erratic or Intermittent Display 9 9
Battery Problem 9 9
Blocked Connection 9 9
Device Issue 9 9
Failure to Advance 9 9
Material Deformation 9 9
Positioning Problem 9 9
Patient Device Interaction Problem 9 9
Intermittent Energy Output 9 9
Protective Measures Problem 8 8
Activation, Positioning or Separation Problem 8 8
Device Sensing Problem 8 8
Difficult or Delayed Activation 7 7
Misfocusing 7 7
Optical Discoloration 7 7
Material Discolored 6 6
Human-Device Interface Problem 6 6
Electrical Power Problem 5 5
Calibration Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Fire 5 5
Device Alarm System 5 5
Continuous Firing 5 5
Loss of Power 5 5
Difficult to Insert 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5954 5954
No Known Impact Or Consequence To Patient 2697 2697
Insufficient Information 658 658
Hemorrhage/Bleeding 487 487
Device Embedded In Tissue or Plaque 462 462
Unspecified Tissue Injury 271 271
Foreign Body In Patient 250 250
Blood Loss 141 141
Injury 136 136
Burn(s) 85 85
No Consequences Or Impact To Patient 80 80
Death 68 68
No Information 60 60
Unspecified Infection 57 57
Bowel Perforation 54 54
Perforation of Vessels 49 49
Hematoma 44 44
Pain 42 42
Failure to Anastomose 40 40
Sepsis 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Tissue Damage 33 33
Burn, Thermal 29 29
Bowel Burn 29 29
No Patient Involvement 26 26
Fistula 23 23
Laceration(s) 21 21
No Code Available 20 20
Hernia 17 17
Unspecified Vascular Problem 16 16
Cardiac Arrest 14 14
Abdominal Pain 14 14
Abscess 14 14
Perforation 13 13
Obstruction/Occlusion 13 13
Great Vessel Perforation 12 12
Adhesion(s) 12 12
Pneumonia 11 11
Internal Organ Perforation 11 11
Nerve Damage 10 10
Low Blood Pressure/ Hypotension 9 9
Ischemia 8 8
Myocardial Infarction 8 8
Seroma 8 8
Fever 8 8
Urinary Tract Infection 8 8
Thrombosis/Thrombus 8 8
Post Operative Wound Infection 7 7
Anemia 7 7
Bruise/Contusion 7 7
Bacterial Infection 7 7
Necrosis 7 7
Liver Laceration(s) 6 6
Wound Dehiscence 6 6
Pulmonary Embolism 6 6
Stroke/CVA 6 6
Pseudoaneurysm 6 6
Fluid Discharge 6 6
Heart Failure/Congestive Heart Failure 6 6
Unspecified Gastrointestinal Problem 5 5
Swelling/ Edema 5 5
Atrial Fibrillation 5 5
Liver Damage/Dysfunction 5 5
Pneumothorax 5 5
Renal Failure 5 5
Pleural Effusion 4 4
Hypoxia 4 4
Arrhythmia 4 4
Swelling 4 4
Impaired Healing 4 4
Peritonitis 4 4
Rectal Anastomotic Leakage 4 4
Vascular Dissection 4 4
Full thickness (Third Degree) Burn 3 3
Unspecified Kidney or Urinary Problem 3 3
Muscle/Tendon Damage 3 3
Skin Infection 3 3
Numbness 3 3
Respiratory Tract Infection 3 3
Incontinence 3 3
Infiltration into Tissue 2 2
Inflammation 2 2
Hypovolemic Shock 2 2
Hemothorax 2 2
Skin Discoloration 2 2
Septic Shock 2 2
Aspiration/Inhalation 2 2
Air Embolism 2 2
Bradycardia 2 2
Erythema 2 2
Exsanguination 2 2
Dehydration 2 2
Purulent Discharge 2 2
Bone Fracture(s) 2 2
Disability 2 2
Low Oxygen Saturation 2 2
Skin Tears 2 2
Superficial (First Degree) Burn 2 2
Diminished Pulse Pressure 2 2
Thromboembolism 2 2

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