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
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 5
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 15
  SE - WITH LIMITATIONS 7
TRANSENTERIX INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 1154 1154
2020 1558 1558
2021 1997 1997
2022 5728 5728
2023 10899 10899
2024 8210 8210

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4523 4523
Break 2804 2804
Material Fragmentation 2803 2803
Visual Prompts will not Clear 2716 2716
Difficult to Open or Close 2465 2465
Material Split, Cut or Torn 1664 1664
Thermal Decomposition of Device 1351 1351
Unintended System Motion 1310 1310
Adverse Event Without Identified Device or Use Problem 1293 1293
Output Problem 1174 1174
Failure to Deliver Energy 1083 1083
No Device Output 669 669
Arcing 662 662
Energy Output Problem 452 452
No Apparent Adverse Event 434 434
Insufficient Information 406 406
No Display/Image 386 386
Material Integrity Problem 353 353
Difficult to Remove 341 341
Unintended Movement 338 338
Defective Device 278 278
Physical Resistance/Sticking 271 271
Material Separation 264 264
Device Displays Incorrect Message 258 258
Material Frayed 251 251
Defective Component 232 232
Failure to Sense 206 206
Entrapment of Device 204 204
Image Orientation Incorrect 201 201
Device Dislodged or Dislocated 192 192
Appropriate Term/Code Not Available 144 144
Mechanical Problem 131 131
Power Problem 126 126
Positioning Failure 110 110
Failure to Cut 105 105
Material Twisted/Bent 89 89
Fracture 86 86
Melted 85 85
Failure to Fire 84 84
Scratched Material 84 84
Crack 78 78
Poor Quality Image 77 77
Firing Problem 65 65
Sparking 63 63
Grounding Malfunction 63 63
Failure to Form Staple 63 63
Smoking 62 62
Display or Visual Feedback Problem 60 60
Use of Device Problem 59 59
Failure to Power Up 57 57

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21687 21687
Insufficient Information 2060 2060
No Known Impact Or Consequence To Patient 2006 2006
Foreign Body In Patient 1410 1410
Hemorrhage/Bleeding 821 821
Unspecified Tissue Injury 629 629
Device Embedded In Tissue or Plaque 323 323
Burn(s) 128 128
Blood Loss 108 108
Injury 106 106
Bowel Perforation 78 78
Perforation of Vessels 65 65
Unspecified Infection 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 60 60
Hematoma 58 58
Death 55 55
No Consequences Or Impact To Patient 52 52
Failure to Anastomose 46 46
Pain 46 46
Sepsis 45 45
Cardiac Arrest 41 41
Laceration(s) 37 37
Fistula 34 34
Bowel Burn 33 33
Great Vessel Perforation 29 29
Hernia 27 27
Bacterial Infection 25 25
Burn, Thermal 21 21
Obstruction/Occlusion 21 21
Tissue Damage 20 20
No Patient Involvement 19 19
Abdominal Pain 19 19
Abscess 18 18
Thrombosis/Thrombus 18 18
Pneumonia 18 18
Seroma 18 18
Low Blood Pressure/ Hypotension 18 18
Pulmonary Embolism 18 18
Unspecified Vascular Problem 17 17
Pneumothorax 17 17
Rectal Anastomotic Leakage 16 16
Perforation 15 15
No Code Available 13 13
Post Operative Wound Infection 13 13
Myocardial Infarction 13 13
Fever 13 13
No Information 13 13
Unspecified Gastrointestinal Problem 13 13
Bruise/Contusion 12 12
Adhesion(s) 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 Apr-11-2024
4 Intuitive Surgical, Inc. II Nov-28-2023
5 Intuitive Surgical, Inc. II Jun-30-2023
6 Intuitive Surgical, Inc. II Mar-28-2023
7 Intuitive Surgical, Inc. II Mar-16-2023
8 Intuitive Surgical, Inc. II Nov-30-2022
9 Intuitive Surgical, Inc. II Oct-25-2022
10 Intuitive Surgical, Inc. II Aug-01-2022
11 Intuitive Surgical, Inc. II Jul-25-2022
12 Intuitive Surgical, Inc. II May-31-2022
13 Intuitive Surgical, Inc. II Apr-22-2022
14 Intuitive Surgical, Inc. II Mar-01-2022
15 Intuitive Surgical, Inc. II Dec-27-2021
16 Intuitive Surgical, Inc. II Nov-23-2021
17 Intuitive Surgical, Inc. II Oct-23-2020
18 Intuitive Surgical, Inc. II Jun-03-2020
19 Intuitive Surgical, Inc. II Jun-01-2020
20 Intuitive Surgical, Inc. II May-11-2020
21 Intuitive Surgical, Inc. II May-06-2020
22 Intuitive Surgical, Inc. II Feb-06-2020
23 Intuitive Surgical, Inc. II Jan-31-2020
24 Intuitive Surgical, Inc. II Jan-24-2020
25 Intuitive Surgical, Inc. II Oct-30-2019
26 Intuitive Surgical, Inc. II Feb-15-2019
27 Olympus Corporation of the Americas II Jun-28-2024
-
-