Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 33
  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 45991 45991

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 27114 27114
Material Fragmentation 7307 7307
Detachment of Device or Device Component 5753 5755
Material Frayed 4971 4971
Break 4437 4440
Difficult to Open or Close 4434 4435
Visual Prompts will not Clear 4165 4167
Output Problem 2365 2365
Thermal Decomposition of Device 2163 2163
Unintended System Motion 2097 2097
Adverse Event Without Identified Device or Use Problem 1806 1807
Unintended Movement 1600 1600
No Apparent Adverse Event 1558 1558
No Device Output 1254 1254
Failure to Deliver Energy 1148 1148
Energy Output Problem 1112 1112
Arcing 893 893
Difficult to Remove 564 564
No Display/Image 480 480
Image Orientation Incorrect 459 459
Insufficient Information 445 445
Material Integrity Problem 434 434
Entrapment of Device 432 432
Physical Resistance/Sticking 376 376
Material Separation 364 364
Device Dislodged or Dislocated 321 321
Defective Device 308 310
Failure to Sense 256 256
Failure to Cut 252 258
Material Twisted/Bent 247 247
Appropriate Term/Code Not Available 211 211
Power Problem 185 185
Positioning Problem 178 178
Failure to Seal 172 172
Mechanical Problem 147 148
Defective Component 145 147
Grounding Malfunction 143 143
Device Displays Incorrect Message 134 136
Display or Visual Feedback Problem 129 130
Positioning Failure 116 116
Scratched Material 114 114
Fracture 96 96
Crack 94 94
Firing Problem 92 94
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 11143 11158
No Known Impact Or Consequence To Patient 1189 1192
Insufficient Information 960 967
Hemorrhage/Bleeding 575 575
Foreign Body In Patient 463 464
Unspecified Tissue Injury 371 371
Device Embedded In Tissue or Plaque 175 175
Burn(s) 86 86
Blood Loss 68 68
Injury 54 54
Perforation of Vessels 54 54
Bowel Perforation 50 50
Unspecified Infection 42 43
Hematoma 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 39
Death 35 35
Failure to Anastomose 33 33
Pain 30 30
Sepsis 28 29
Laceration(s) 25 25
No Consequences Or Impact To Patient 23 23
Fistula 21 22
Bowel Burn 20 20
Cardiac Arrest 19 19
Great Vessel Perforation 19 19
Unspecified Vascular Problem 16 16
Hernia 14 14
Obstruction/Occlusion 13 13
Perforation 12 12
No Patient Involvement 12 12
Abdominal Pain 12 13
Pneumonia 11 11
Seroma 11 11
Tissue Damage 11 11
Ischemia 10 10
Abscess 10 10
Low Blood Pressure/ Hypotension 10 10
Myocardial Infarction 10 10
Nerve Damage 10 10
Burn, Thermal 9 10
Thrombosis/Thrombus 9 9
Urinary Tract Infection 9 9
Necrosis 8 8
Internal Organ Perforation 8 9
Adhesion(s) 8 8
Bacterial Infection 8 8
Post Operative Wound Infection 8 8
Pneumothorax 8 8
Bruise/Contusion 7 7
Pseudoaneurysm 7 7

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
-
-