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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
Regulation Description Endoscope and accessories.
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
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 5
  SUBSTANTIALLY EQUIVALENT 42
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2016 1074 1074
2017 1049 1049
2018 1074 1074
2019 1154 1154
2020 1558 1558
2021 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2400 2400
Device Displays Incorrect Message 643 643
Detachment of Device or Device Component 500 500
Device Operates Differently Than Expected 365 365
Failure to Deliver Energy 348 348
Detachment Of Device Component 337 337
Arcing 323 323
Defective Component 282 282
Insufficient Information 281 281
Difficult to Open or Close 236 236
Adverse Event Without Identified Device or Use Problem 153 153
Cable, Electrical 149 149
Wire 128 128
Electrical /Electronic Property Problem 127 127
Thermal Decomposition of Device 123 123
Material Fragmentation 121 121
Tip 120 120
Device Or Device Fragments Location Unknown 98 98
Material Split, Cut or Torn 81 81
Device Dislodged or Dislocated 61 61
Component Falling 60 60
Melted 57 57
Mechanical Problem 55 55
Knife 51 51
Defective Device 50 50
Device Inoperable 47 47
No Display/Image 46 46
Jaw 43 43
Failure to Cut 41 41
Loose or Intermittent Connection 38 38
Poor Quality Image 38 38
Mechanical Jam 36 36
Component Missing 35 35
Material Protrusion/Extrusion 32 32
Misfire 32 32
Material Frayed 31 31
Smoking 30 30
Difficult to Remove 28 28
Retraction Problem 28 28
No Device Output 28 28
Failure to Form Staple 28 28
Device Issue 26 26
Material Separation 25 25
Therapeutic or Diagnostic Output Failure 25 25
Use of Device Problem 22 22
Material Twisted/Bent 22 22
Appropriate Term/Code Not Available 20 20
Output Problem 19 19
Crack 19 19
Cover 18 18
Physical Resistance/Sticking 17 17
Nonstandard Device 17 17
Failure to Power Up 16 16
Sticking 16 16
Failure to Fire 16 16
Improper or Incorrect Procedure or Method 15 15
Entrapment of Device 15 15
Mechanics Altered 15 15
Insulation 15 15
Bent 14 14
Loss of Power 14 14
Torn Material 14 14
Device Slipped 13 13
Failure to Calibrate 13 13
Power Problem 13 13
Failure To Adhere Or Bond 12 12
Energy Output Problem 11 11
Cannula 11 11
Display or Visual Feedback Problem 11 11
Degraded 11 11
Sparking 11 11
Needle 10 10
Positioning Problem 10 10
Staple 10 10
Scratched Material 9 9
Device Fell 9 9
Energy Output To Patient Tissue Incorrect 9 9
Device Stops Intermittently 9 9
Failure to Align 9 9
Fracture 8 8
Computer Operating System Problem 8 8
Communication or Transmission Problem 8 8
Noise, Audible 8 8
Malposition of Device 8 8
Leak/Splash 8 8
Device Alarm System 8 8
Device Sensing Problem 8 8
Material Deformation 7 7
Driver 7 7
Dull, Blunt 7 7
Failure to Advance 7 7
No Apparent Adverse Event 7 7
Hole In Material 6 6
Failure to Sense 6 6
Connection Problem 6 6
Shaft 6 6
Computer Software Problem 6 6
Failure of Device to Self-Test 5 5
Device Subassembly 5 5
Ring 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4045 4045
Device Embedded In Tissue or Plaque 595 595
No Consequences Or Impact To Patient 252 252
Foreign Body In Patient 224 224
Blood Loss 198 198
Injury 186 186
No Information 125 125
Death 99 99
No Patient Involvement 80 80
Tissue Damage 64 64
Hemorrhage/Bleeding 51 51
No Clinical Signs, Symptoms or Conditions 47 47
Burn, Thermal 37 37
Burn(s) 34 34
Failure to Anastomose 33 33
No Code Available 33 33
Unspecified Infection 32 32
Insufficient Information 32 32
Pain 30 30
Bowel Burn 23 23
Bowel Perforation 22 22
Sepsis 16 16
Hematoma 11 11
Abscess 10 10
Perforation 8 8
Internal Organ Perforation 7 7
Nerve Damage 6 6
Fistula 6 6
Abdominal Pain 6 6
Swelling 6 6
Fever 6 6
Hernia 6 6
Wound Dehiscence 5 5
Septic Shock 5 5
Bacterial Infection 5 5
Bruise/Contusion 5 5
Laceration(s) 5 5
Complaint, Ill-Defined 5 5
Adhesion(s) 4 4
Incontinence 4 4
Nausea 3 3
Embolism 3 3
Obstruction/Occlusion 3 3
Post Operative Wound Infection 3 3
Full thickness (Third Degree) Burn 3 3
Skin Discoloration 3 3
Perforation of Vessels 3 3
Low Blood Pressure/ Hypotension 3 3
Erythema 3 3
Rupture 3 3
Coma 3 3
Multiple Organ Failure 3 3
Cancer 2 2
Vascular Dissection 2 2
Hematuria 2 2
Abdominal Distention 2 2
Discharge 2 2
Deformity/ Disfigurement 2 2
Aspiration/Inhalation 2 2
Pulmonary Embolism 2 2
Inflammation 2 2
Impaired Healing 2 2
Depression 2 2
Disability 2 2
Heart Failure 2 2
Headache 2 2
Liver Laceration(s) 2 2
Bone Fracture(s) 2 2
Scarring 2 2
Pleural Effusion 2 2
Vomiting 2 2
Urinary Tract Infection 2 2
Blurred Vision 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Burning Sensation 1 1
Dizziness 1 1
Urinary Retention 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Tachycardia 1 1
Tinnitus 1 1
Micturition Urgency 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Adult Respiratory Distress Syndrome 1 1
Cardiac Arrest 1 1
Necrosis 1 1
Hemothorax 1 1
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Discomfort 1 1
Joint Disorder 1 1
Reaction 1 1
Pseudoaneurysm 1 1
Not Applicable 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intuitive Surgical Inc II May-05-2020
2 Intuitive Surgical, Inc. II Oct-23-2020
3 Intuitive Surgical, Inc. II Jun-03-2020
4 Intuitive Surgical, Inc. II Jun-01-2020
5 Intuitive Surgical, Inc. II May-11-2020
6 Intuitive Surgical, Inc. II May-06-2020
7 Intuitive Surgical, Inc. II Feb-06-2020
8 Intuitive Surgical, Inc. II Jan-31-2020
9 Intuitive Surgical, Inc. II Jan-24-2020
10 Intuitive Surgical, Inc. II Oct-30-2019
11 Intuitive Surgical, Inc. II Feb-15-2019
12 Intuitive Surgical, Inc. II Sep-26-2018
13 Intuitive Surgical, Inc. II Sep-12-2018
14 Intuitive Surgical, Inc. II Aug-16-2018
15 Intuitive Surgical, Inc. II Jul-02-2018
16 Intuitive Surgical, Inc. II Jan-23-2018
17 Intuitive Surgical, Inc. II Jun-06-2017
18 Intuitive Surgical, Inc. II Apr-13-2017
19 Intuitive Surgical, Inc. II Apr-05-2017
20 Intuitive Surgical, Inc. II Oct-26-2016
21 Intuitive Surgical, Inc. II Aug-26-2016
22 Intuitive Surgical, Inc. II Aug-05-2016
23 Intuitive Surgical, Inc. II May-27-2016
24 Intuitive Surgical, Inc. II Apr-26-2016
25 Intuitive Surgical, Inc. II Apr-12-2016
26 Intuitive Surgical, Inc. II Mar-18-2016
27 Intuitive Surgical, Inc. II Jan-14-2016
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