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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
AKTORMED GMBH
  SUBSTANTIALLY EQUIVALENT 2
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 6
INTUITIVE SURGICAL INC.
  SE - WITH LIMITATIONS 1
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 7
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 6
  SUBSTANTIALLY EQUIVALENT 31
TRANSENTERIX INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2016 1076 1076
2017 1049 1049
2018 1074 1074
2019 1154 1154
2020 1558 1558
2021 1173 1173

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2462 2462
Detachment of Device or Device Component 855 855
Device Displays Incorrect Message 645 645
Failure to Deliver Energy 405 405
Device Operates Differently Than Expected 366 366
Arcing 350 350
Detachment Of Device Component 337 337
Insufficient Information 306 306
Difficult to Open or Close 289 289
Defective Component 283 283
Material Split, Cut or Torn 247 247
Adverse Event Without Identified Device or Use Problem 219 219
Thermal Decomposition of Device 165 165
Material Fragmentation 129 129
Electrical /Electronic Property Problem 127 127
Device Or Device Fragments Location Unknown 98 98
Device Dislodged or Dislocated 77 77
Mechanical Problem 67 67
No Display/Image 64 64
Melted 60 60
Component Falling 60 60
Defective Device 55 55
Failure to Cut 51 51
Material Separation 51 51
Visual Prompts will not Clear 50 50
Device Inoperable 47 47
Material Frayed 45 45
Misfire 41 41
No Device Output 41 41
Mechanical Jam 40 40
Loose or Intermittent Connection 40 40
Poor Quality Image 39 39
Component Missing 37 37
Material Protrusion/Extrusion 36 36
Smoking 34 34
Difficult to Remove 34 34
Failure to Form Staple 34 34
Retraction Problem 32 32
Output Problem 31 31
Therapeutic or Diagnostic Output Failure 31 31
Energy Output Problem 28 28
Physical Resistance/Sticking 26 26
Device Issue 26 26
Use of Device Problem 26 26
Material Twisted/Bent 24 24
Crack 23 23
Failure to Fire 23 23
Entrapment of Device 22 22
Appropriate Term/Code Not Available 22 22
Failure to Power Up 21 21
Nonstandard Device 18 18
Improper or Incorrect Procedure or Method 16 16
Sticking 16 16
Mechanics Altered 15 15
Failure to Calibrate 15 15
Device Slipped 15 15
Loss of Power 14 14
Display or Visual Feedback Problem 14 14
Bent 14 14
Torn Material 14 14
Device Fell 14 14
Power Problem 13 13
Fracture 13 13
Failure to Align 13 13
Sparking 13 13
Positioning Problem 12 12
Dull, Blunt 12 12
Failure To Adhere Or Bond 12 12
Device Sensing Problem 11 11
Degraded 11 11
Noise, Audible 10 10
Failure to Advance 10 10
Device Stops Intermittently 9 9
Scratched Material 9 9
Energy Output To Patient Tissue Incorrect 9 9
Communication or Transmission Problem 8 8
No Apparent Adverse Event 8 8
Computer Operating System Problem 8 8
Malposition of Device 8 8
Connection Problem 8 8
Material Deformation 8 8
Leak/Splash 8 8
Device Alarm System 8 8
Unintended System Motion 7 7
Failure to Sense 7 7
Positioning Failure 6 6
Hole In Material 6 6
Computer Software Problem 6 6
Unintended Movement 6 6
Firing Problem 6 6
Activation Failure 5 5
Failure of Device to Self-Test 5 5
Difficult To Position 5 5
Calibration Problem 5 5
Activation, Positioning or SeparationProblem 5 5
Protective Measures Problem 5 5
Device Damaged by Another Device 4 4
Material Puncture/Hole 4 4
Migration or Expulsion of Device 4 4
Material Integrity Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4045 4045
No Clinical Signs, Symptoms or Conditions 824 824
Device Embedded In Tissue or Plaque 595 595
No Consequences Or Impact To Patient 252 252
Foreign Body In Patient 245 245
Blood Loss 198 198
Injury 186 186
Insufficient Information 179 179
No Information 125 125
Hemorrhage/Bleeding 109 110
Death 99 99
No Patient Involvement 80 80
Tissue Damage 65 65
Burn(s) 43 43
Burn, Thermal 37 37
Pain 36 38
Failure to Anastomose 35 35
Unspecified Infection 33 33
No Code Available 33 33
Bowel Perforation 30 31
Bowel Burn 25 25
Unspecified Tissue Injury 25 25
Sepsis 19 19
Hematoma 15 15
Abscess 11 11
Perforation 10 10
Hernia 9 9
Fistula 9 9
Nerve Damage 7 7
Internal Organ Perforation 7 7
Septic Shock 7 7
Perforation of Vessels 7 7
Swelling 6 6
Low Blood Pressure/ Hypotension 6 7
Fever 6 6
Laceration(s) 6 6
Abdominal Pain 6 6
Bacterial Infection 5 5
Bruise/Contusion 5 5
Cardiac Arrest 5 6
Incontinence 5 5
Complaint, Ill-Defined 5 5
Wound Dehiscence 5 5
Unspecified Vascular Problem 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Obstruction/Occlusion 4 4
Adhesion(s) 4 4
Nausea 4 4
Pleural Effusion 4 4
Embolism 3 3
Post Operative Wound Infection 3 3
Full thickness (Third Degree) Burn 3 3
Depression 3 3
Fluid Discharge 3 3
Multiple Organ Failure 3 3
Rupture 3 3
Coma 3 3
Erythema 3 3
Skin Discoloration 3 3
Impotence 2 2
Inflammation 2 2
Pulmonary Embolism 2 2
Anemia 2 2
Aspiration/Inhalation 2 2
Hematuria 2 2
Abdominal Distention 2 2
Discharge 2 2
Deformity/ Disfigurement 2 2
Cancer 2 2
Vascular Dissection 2 2
Disability 2 2
Impaired Healing 2 2
Vomiting 2 2
Heart Failure 2 2
Anxiety 2 2
Discomfort 2 2
Pseudoaneurysm 2 2
Headache 2 2
Bone Fracture(s) 2 2
Liver Laceration(s) 2 2
Scarring 2 2
Urinary Tract Infection 2 2
Blurred Vision 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Tachycardia 1 1
Tinnitus 1 1
Urinary Retention 1 1
Pneumonia 1 2
Pneumothorax 1 1
Pulmonary Edema 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Necrosis 1 1
Hemothorax 1 1
Hypoxia 1 1
Micturition Urgency 1 1
Adult Respiratory Distress Syndrome 1 1
Diarrhea 1 1
Purulent Discharge 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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