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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
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 36
  SE - WITH LIMITATIONS 8
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1997 2001
2022 5727 5742
2023 10898 10902
2024 12872 12872
2025 49305 49305
2026 19827 19827

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 38734 38734
Material Frayed 7884 7884
Material Fragmentation 7547 7547
Detachment of Device or Device Component 6114 6116
Visual Prompts will not Clear 5645 5645
Difficult to Open or Close 4972 4973
Break 4772 4775
Output Problem 3416 3416
Unintended System Motion 2383 2383
Thermal Decomposition of Device 2250 2250
Unintended Movement 2164 2164
No Apparent Adverse Event 2134 2134
Adverse Event Without Identified Device or Use Problem 1898 1898
No Device Output 1593 1593
Energy Output Problem 1313 1313
Failure to Deliver Energy 1107 1107
Arcing 861 861
Difficult to Remove 645 645
Image Orientation Incorrect 538 538
No Display/Image 531 531
Entrapment of Device 494 494
Material Integrity Problem 491 491
Insufficient Information 449 449
Physical Resistance/Sticking 420 420
Material Separation 419 419
Material Twisted/Bent 378 378
Device Dislodged or Dislocated 346 346
Failure to Cut 305 311
Defective Device 303 305
Failure to Sense 291 291
Positioning Problem 263 263
Failure to Seal 243 243
Appropriate Term/Code Not Available 239 239
Power Problem 222 222
Grounding Malfunction 171 171
Display or Visual Feedback Problem 156 157
Mechanical Problem 143 144
Failure to Power Up 134 134
Scratched Material 132 132
Positioning Failure 128 128
Use of Device Problem 109 109
Crack 102 102
Firing Problem 99 101
Fracture 95 95
Unexpected Shutdown 95 95
Poor Quality Image 87 87
Continuous Firing 79 79
Sparking 78 78
Failure to Fire 78 79
Connection Problem 73 75

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79146 79161
Insufficient Information 16530 16536
Foreign Body In Patient 1691 1692
Unspecified Tissue Injury 1392 1392
Hemorrhage/Bleeding 1315 1315
Burn(s) 196 196
Bowel Perforation 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 86
Hematoma 85 85
No Known Impact Or Consequence To Patient 85 85
Perforation of Vessels 83 83
Unspecified Infection 78 79
Cardiac Arrest 76 76
Failure to Anastomose 60 60
Sepsis 59 60
Fistula 57 58
Pain 55 55
Bacterial Infection 53 53
Great Vessel Perforation 51 51
Hernia 47 47
Laceration(s) 44 44
Obstruction/Occlusion 41 41
Pneumothorax 41 41
Abscess 38 38
Pulmonary Embolism 35 35
Seroma 33 33
Thrombosis/Thrombus 31 31
Abdominal Pain 27 28
Pneumonia 27 27
Post Operative Wound Infection 27 27
Low Blood Pressure/ Hypotension 27 27
Bowel Burn 26 26
Unspecified Gastrointestinal Problem 24 24
Myocardial Infarction 24 24
Pleural Effusion 22 22
Unspecified Vascular Problem 21 21
Rectal Anastomotic Leakage 21 21
Ischemia 21 21
Urinary Tract Infection 20 20
Necrosis 20 20
Device Embedded In Tissue or Plaque 20 20
Fever 19 19
Unspecified Kidney or Urinary Problem 19 19
Bruise/Contusion 18 18
Perforation 18 18
Respiratory Tract Infection 17 17
Stroke/CVA 16 16
Respiratory Failure 16 16
Fluid Discharge 15 15
Adhesion(s) 15 15

Recalls
Manufacturer Recall Class Date Posted
1 Asensus Surgical Inc I Oct-30-2023
2 Intuitive Surgical, Inc. II Mar-30-2026
3 Intuitive Surgical, Inc. II Mar-30-2026
4 Intuitive Surgical, Inc. II Feb-18-2026
5 Intuitive Surgical, Inc. II Feb-12-2026
6 Intuitive Surgical, Inc. II Feb-02-2026
7 Intuitive Surgical, Inc. II Jan-15-2026
8 Intuitive Surgical, Inc. II Dec-19-2025
9 Intuitive Surgical, Inc. II Mar-12-2025
10 Intuitive Surgical, Inc. II Jan-16-2025
11 Intuitive Surgical, Inc. II Jan-10-2025
12 Intuitive Surgical, Inc. II Apr-11-2024
13 Intuitive Surgical, Inc. II Nov-28-2023
14 Intuitive Surgical, Inc. II Jun-30-2023
15 Intuitive Surgical, Inc. II Mar-28-2023
16 Intuitive Surgical, Inc. II Mar-16-2023
17 Intuitive Surgical, Inc. II Nov-30-2022
18 Intuitive Surgical, Inc. II Oct-25-2022
19 Intuitive Surgical, Inc. II Aug-01-2022
20 Intuitive Surgical, Inc. II Jul-25-2022
21 Intuitive Surgical, Inc. II May-31-2022
22 Intuitive Surgical, Inc. II Apr-22-2022
23 Intuitive Surgical, Inc. II Mar-01-2022
24 Intuitive Surgical, Inc. II Dec-27-2021
25 Intuitive Surgical, Inc. II Nov-23-2021
26 Olympus Corporation of the Americas II Jun-28-2024
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