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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 1
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 3
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
  SE - WITH LIMITATIONS 8
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1558 1558
2021 1997 1997
2022 5728 5728
2023 10899 10899
2024 12872 12872
2025 12052 12052

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 7301 7301
Material Fragmentation 6394 6394
Detachment of Device or Device Component 4958 4958
Visual Prompts will not Clear 3312 3312
Break 3232 3232
Difficult to Open or Close 3150 3150
Thermal Decomposition of Device 1816 1816
Output Problem 1583 1583
Unintended System Motion 1575 1575
Adverse Event Without Identified Device or Use Problem 1543 1543
Material Frayed 1246 1246
Failure to Deliver Energy 1044 1044
No Device Output 869 869
Unintended Movement 799 799
Energy Output Problem 734 734
Arcing 706 706
No Apparent Adverse Event 698 698
Difficult to Remove 436 436
No Display/Image 410 410
Material Integrity Problem 377 377
Insufficient Information 370 370
Entrapment of Device 306 306
Physical Resistance/Sticking 304 304
Material Separation 295 295
Image Orientation Incorrect 286 286
Defective Device 270 270
Device Dislodged or Dislocated 247 247
Failure to Sense 219 219
Appropriate Term/Code Not Available 163 163
Power Problem 143 143
Failure to Cut 139 139
Material Twisted/Bent 136 136
Device Displays Incorrect Message 133 133
Defective Component 131 131
Mechanical Problem 129 129
Positioning Failure 112 112
Positioning Problem 103 103
Grounding Malfunction 96 96
Fracture 91 91
Display or Visual Feedback Problem 86 86
Scratched Material 86 86
Melted 85 85
Failure to Fire 82 82
Poor Quality Image 81 81
Crack 81 81
Firing Problem 79 79
Sparking 66 66
Failure to Form Staple 65 65
Smoking 65 65
Failure to Power Up 64 64

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35095 35095
Insufficient Information 4602 4602
Foreign Body In Patient 1607 1607
No Known Impact Or Consequence To Patient 1189 1189
Hemorrhage/Bleeding 992 992
Unspecified Tissue Injury 886 886
Device Embedded In Tissue or Plaque 182 182
Burn(s) 159 159
Bowel Perforation 81 81
Perforation of Vessels 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Blood Loss 68 68
Hematoma 66 66
Unspecified Infection 60 60
Injury 54 54
Failure to Anastomose 50 50
Cardiac Arrest 50 50
Sepsis 48 48
Fistula 45 45
Pain 44 44
Laceration(s) 39 39
Hernia 39 39
Bacterial Infection 35 35
Death 35 35
Great Vessel Perforation 33 33
Pneumothorax 30 30
Bowel Burn 29 29
Pulmonary Embolism 27 27
Obstruction/Occlusion 27 27
Seroma 26 26
Abscess 25 25
No Consequences Or Impact To Patient 23 23
Post Operative Wound Infection 22 22
Abdominal Pain 22 22
Pneumonia 21 21
Rectal Anastomotic Leakage 21 21
Low Blood Pressure/ Hypotension 20 20
Thrombosis/Thrombus 19 19
Unspecified Vascular Problem 18 18
Myocardial Infarction 17 17
Perforation 17 17
Necrosis 16 16
Fever 15 15
Pleural Effusion 15 15
Bruise/Contusion 15 15
Ischemia 15 15
Unspecified Gastrointestinal Problem 14 14
Nerve Damage 14 14
Fluid Discharge 14 14
Internal Organ Perforation 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Asensus Surgical Inc I Oct-30-2023
2 Intuitive Surgical Inc II May-05-2020
3 Intuitive Surgical, Inc. II Mar-12-2025
4 Intuitive Surgical, Inc. II Jan-16-2025
5 Intuitive Surgical, Inc. II Jan-10-2025
6 Intuitive Surgical, Inc. II Apr-11-2024
7 Intuitive Surgical, Inc. II Nov-28-2023
8 Intuitive Surgical, Inc. II Jun-30-2023
9 Intuitive Surgical, Inc. II Mar-28-2023
10 Intuitive Surgical, Inc. II Mar-16-2023
11 Intuitive Surgical, Inc. II Nov-30-2022
12 Intuitive Surgical, Inc. II Oct-25-2022
13 Intuitive Surgical, Inc. II Aug-01-2022
14 Intuitive Surgical, Inc. II Jul-25-2022
15 Intuitive Surgical, Inc. II May-31-2022
16 Intuitive Surgical, Inc. II Apr-22-2022
17 Intuitive Surgical, Inc. II Mar-01-2022
18 Intuitive Surgical, Inc. II Dec-27-2021
19 Intuitive Surgical, Inc. II Nov-23-2021
20 Intuitive Surgical, Inc. II Oct-23-2020
21 Intuitive Surgical, Inc. II Jun-03-2020
22 Intuitive Surgical, Inc. II Jun-01-2020
23 Intuitive Surgical, Inc. II May-11-2020
24 Intuitive Surgical, Inc. II May-06-2020
25 Intuitive Surgical, Inc. II Feb-06-2020
26 Intuitive Surgical, Inc. II Jan-31-2020
27 Intuitive Surgical, Inc. II Jan-24-2020
28 Olympus Corporation of the Americas II Jun-28-2024
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