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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 5
INTUITIVE SURGICAL INC.
  SE - WITH LIMITATIONS 1
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 7
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 7
  SUBSTANTIALLY EQUIVALENT 26
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 1992 1992

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2069 2069
Detachment of Device or Device Component 1051 1051
Device Displays Incorrect Message 543 543
Failure to Deliver Energy 422 422
Arcing 358 358
Material Split, Cut or Torn 358 358
Adverse Event Without Identified Device or Use Problem 314 314
Difficult to Open or Close 305 305
Insufficient Information 286 286
Defective Component 279 279
Detachment Of Device Component 276 276
Device Operates Differently Than Expected 232 232
Thermal Decomposition of Device 188 188
Material Fragmentation 127 127
Electrical /Electronic Property Problem 102 102
Visual Prompts will not Clear 94 94
Device Dislodged or Dislocated 84 84
Device Or Device Fragments Location Unknown 82 82
No Display/Image 71 71
Material Separation 60 60
Melted 58 58
Mechanical Problem 57 57
Defective Device 52 52
No Device Output 46 46
Failure to Cut 45 45
Therapeutic or Diagnostic Output Failure 43 43
Output Problem 38 38
Poor Quality Image 36 36
Material Frayed 36 36
Difficult to Remove 35 35
Mechanical Jam 34 34
Energy Output Problem 33 33
Misfire 31 31
Material Protrusion/Extrusion 30 30
Physical Resistance/Sticking 28 28
Failure to Fire 27 27
Unintended System Motion 27 27
Retraction Problem 27 27
Smoking 26 26
Device Issue 26 26
Component Missing 25 25
Use of Device Problem 24 24
Crack 22 22
Dull, Blunt 21 21
Material Twisted/Bent 20 20
Appropriate Term/Code Not Available 20 20
Unintended Movement 19 19
Device Inoperable 19 19
Entrapment of Device 19 19
Loose or Intermittent Connection 19 19
Failure to Form Staple 18 18
Power Problem 17 17
Display or Visual Feedback Problem 16 16
Component Falling 16 16
Failure to Power Up 15 15
Device Fell 15 15
Device Slipped 14 14
Failure to Calibrate 14 14
Failure to Align 13 13
Scratched Material 12 12
Degraded 11 11
Fracture 10 10
Bent 10 10
Sparking 10 10
Noise, Audible 10 10
Loss of Power 9 9
Device Sensing Problem 8 8
Material Deformation 7 7
Sticking 7 7
Firing Problem 7 7
Protective Measures Problem 7 7
Positioning Problem 6 6
Device Alarm System 6 6
Computer Software Problem 6 6
Positioning Failure 6 6
Energy Output To Patient Tissue Incorrect 6 6
Mechanics Altered 6 6
Connection Problem 6 6
Failure to Advance 6 6
Failure to Sense 6 6
Improper or Incorrect Procedure or Method 6 6
Calibration Problem 5 5
Malposition of Device 5 5
Activation, Positioning or SeparationProblem 5 5
Material Integrity Problem 5 5
Torn Material 5 5
Activation Failure 5 5
No Apparent Adverse Event 4 4
Intermittent Energy Output 4 4
Activation Problem 4 4
Electrical Shorting 4 4
Image Orientation Incorrect 4 4
Device Stops Intermittently 3 3
Stretched 3 3
Material Puncture/Hole 3 3
Premature Activation 3 3
Peeled/Delaminated 3 3
Material Discolored 3 3
Disconnection 3 3
Fire 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3383 3383
No Clinical Signs, Symptoms or Conditions 1374 1374
Device Embedded In Tissue or Plaque 557 557
Insufficient Information 298 298
Foreign Body In Patient 231 231
Blood Loss 178 178
Injury 160 160
Hemorrhage/Bleeding 130 130
No Consequences Or Impact To Patient 121 121
No Information 93 93
Death 82 82
Unspecified Tissue Injury 70 70
Tissue Damage 53 53
Burn(s) 45 45
No Patient Involvement 36 36
Unspecified Infection 33 33
Burn, Thermal 32 32
Pain 28 28
Bowel Perforation 27 27
Failure to Anastomose 25 25
Bowel Burn 25 25
No Code Available 24 24
Hematoma 18 18
Sepsis 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Fistula 12 12
Nerve Damage 10 10
Perforation of Vessels 9 9
Hernia 9 9
Unspecified Vascular Problem 8 8
Perforation 8 8
Abscess 8 8
Internal Organ Perforation 7 7
Obstruction/Occlusion 7 7
Adhesion(s) 6 6
Cardiac Arrest 6 6
Abdominal Pain 6 6
Bruise/Contusion 5 5
Wound Dehiscence 5 5
Fever 5 5
Low Blood Pressure/ Hypotension 5 5
Stroke/CVA 4 4
Swelling 4 4
Pleural Effusion 4 4
Laceration(s) 4 4
Liver Laceration(s) 3 3
Necrosis 3 3
Septic Shock 3 3
Pulmonary Embolism 3 3
Anemia 3 3
Pseudoaneurysm 3 3
Fluid Discharge 3 3
Full thickness (Third Degree) Burn 3 3
Thrombosis/Thrombus 3 3
Cancer 3 3
Multiple Organ Failure 2 2
Vascular Dissection 2 2
Respiratory Tract Infection 2 2
Hematuria 2 2
Deformity/ Disfigurement 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Disability 2 2
Arrhythmia 2 2
Bacterial Infection 2 2
Hemothorax 2 2
Incontinence 2 2
Bone Fracture(s) 2 2
Exsanguination 2 2
Embolism 2 2
Seroma 2 2
Urinary Tract Infection 2 2
Heart Failure 2 2
Rupture 2 2
Ischemia 2 2
Pneumonia 2 2
Pneumothorax 1 1
Rash 1 1
Renal Failure 1 1
Scar Tissue 1 1
Scarring 1 1
Muscle Weakness 1 1
Nausea 1 1
Liver Damage/Dysfunction 1 1
Inflammation 1 1
Visual Impairment 1 1
Visual Disturbances 1 1
Vomiting 1 1
Burning Sensation 1 1
Skin Discoloration 1 1
Spinal Column Injury 1 1
Urinary Retention 1 1
Erythema 1 1
Micturition Urgency 1 1
Headache 1 1
Flatus 1 1
Hypovolemic Shock 1 1
Hypoxia 1 1
Hemorrhage, Cerebral 1 1
Bradycardia 1 1

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