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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 35
  SE - WITH LIMITATIONS 11
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1558 1563
2021 1997 2001
2022 5727 5742
2023 10898 10902
2024 12872 12872
2025 49304 49304

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 28740 28740
Material Fragmentation 7371 7371
Detachment of Device or Device Component 5845 5847
Material Frayed 5295 5295
Break 4634 4637
Difficult to Open or Close 4584 4585
Visual Prompts will not Clear 4266 4268
Output Problem 2453 2453
Thermal Decomposition of Device 2217 2217
Unintended System Motion 2157 2157
Adverse Event Without Identified Device or Use Problem 1853 1854
Unintended Movement 1699 1699
No Apparent Adverse Event 1608 1608
No Device Output 1327 1327
Energy Output Problem 1166 1166
Failure to Deliver Energy 1165 1165
Arcing 923 923
Difficult to Remove 599 599
No Display/Image 496 496
Image Orientation Incorrect 483 483
Insufficient Information 462 462
Entrapment of Device 451 451
Material Integrity Problem 440 440
Material Separation 384 384
Physical Resistance/Sticking 384 384
Device Dislodged or Dislocated 332 332
Defective Device 308 310
Material Twisted/Bent 272 272
Failure to Sense 262 262
Failure to Cut 261 267
Appropriate Term/Code Not Available 216 216
Failure to Seal 204 204
Positioning Problem 191 191
Power Problem 186 186
Grounding Malfunction 152 152
Mechanical Problem 148 149
Defective Component 145 147
Display or Visual Feedback Problem 135 136
Device Displays Incorrect Message 135 137
Scratched Material 122 122
Positioning Failure 117 117
Crack 98 98
Fracture 96 96
Firing Problem 93 95
Poor Quality Image 89 89
Melted 86 86
Unexpected Shutdown 84 84
Failure to Fire 82 83
Smoking 80 80
Use of Device Problem 79 79

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64143 64158
Insufficient Information 12056 12063
Foreign Body In Patient 1703 1704
Unspecified Tissue Injury 1275 1275
Hemorrhage/Bleeding 1233 1233
No Known Impact Or Consequence To Patient 1189 1192
Burn(s) 196 196
Device Embedded In Tissue or Plaque 183 183
Bowel Perforation 98 98
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 84 85
Perforation of Vessels 79 79
Hematoma 79 79
Cardiac Arrest 72 72
Unspecified Infection 71 72
Blood Loss 68 68
Sepsis 58 59
Failure to Anastomose 56 56
Injury 54 54
Pain 53 53
Fistula 51 52
Bacterial Infection 49 49
Hernia 46 46
Great Vessel Perforation 44 44
Laceration(s) 43 43
Obstruction/Occlusion 38 38
Pneumothorax 38 38
Pulmonary Embolism 36 36
Death 35 35
Seroma 31 31
Bowel Burn 31 31
Abscess 31 31
Thrombosis/Thrombus 29 29
Post Operative Wound Infection 25 25
Low Blood Pressure/ Hypotension 25 25
Pneumonia 25 25
Abdominal Pain 25 26
Myocardial Infarction 24 24
No Consequences Or Impact To Patient 23 23
Ischemia 21 21
Unspecified Vascular Problem 21 21
Rectal Anastomotic Leakage 21 21
Pleural Effusion 20 20
Unspecified Gastrointestinal Problem 19 19
Perforation 19 19
Necrosis 19 19
Bruise/Contusion 18 18
Urinary Tract Infection 17 17
Fever 17 17
Nerve Damage 16 16
Respiratory Tract Infection 15 15

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 Jan-15-2026
4 Intuitive Surgical, Inc. II Dec-19-2025
5 Intuitive Surgical, Inc. II Mar-12-2025
6 Intuitive Surgical, Inc. II Jan-16-2025
7 Intuitive Surgical, Inc. II Jan-10-2025
8 Intuitive Surgical, Inc. II Apr-11-2024
9 Intuitive Surgical, Inc. II Nov-28-2023
10 Intuitive Surgical, Inc. II Jun-30-2023
11 Intuitive Surgical, Inc. II Mar-28-2023
12 Intuitive Surgical, Inc. II Mar-16-2023
13 Intuitive Surgical, Inc. II Nov-30-2022
14 Intuitive Surgical, Inc. II Oct-25-2022
15 Intuitive Surgical, Inc. II Aug-01-2022
16 Intuitive Surgical, Inc. II Jul-25-2022
17 Intuitive Surgical, Inc. II May-31-2022
18 Intuitive Surgical, Inc. II Apr-22-2022
19 Intuitive Surgical, Inc. II Mar-01-2022
20 Intuitive Surgical, Inc. II Dec-27-2021
21 Intuitive Surgical, Inc. II Nov-23-2021
22 Intuitive Surgical, Inc. II Oct-23-2020
23 Intuitive Surgical, Inc. II Jun-03-2020
24 Intuitive Surgical, Inc. II Jun-01-2020
25 Intuitive Surgical, Inc. II May-11-2020
26 Intuitive Surgical, Inc. II May-06-2020
27 Intuitive Surgical, Inc. II Feb-06-2020
28 Intuitive Surgical, Inc. II Jan-31-2020
29 Intuitive Surgical, Inc. II Jan-24-2020
30 Olympus Corporation of the Americas II Jun-28-2024
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