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
ASENSUS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 37
  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 33444 33446

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 43315 43315
Material Frayed 9108 9108
Material Fragmentation 7779 7779
Visual Prompts will not Clear 6815 6815
Detachment of Device or Device Component 6425 6427
Difficult to Open or Close 5538 5538
Break 5235 5235
Output Problem 4509 4509
Unintended System Motion 2745 2746
Unintended Movement 2566 2566
No Apparent Adverse Event 2537 2537
Thermal Decomposition of Device 2440 2440
Adverse Event Without Identified Device or Use Problem 2044 2044
No Device Output 1922 1922
Energy Output Problem 1505 1505
Failure to Deliver Energy 1156 1156
Arcing 943 943
Difficult to Remove 705 705
Image Orientation Incorrect 607 607
No Display/Image 586 586
Material Integrity Problem 557 557
Material Twisted/Bent 552 552
Entrapment of Device 523 523
Insufficient Device Problem Information 512 512
Material Separation 465 465
Physical Resistance/Sticking 454 454
Device Dislodged or Dislocated 426 426
Positioning Problem 364 364
Failure to Sense 323 323
Failure to Seal 306 306
Failure to Cut 303 303
Appropriate Device Problem Term/Code Not Available 291 291
Power Problem 264 264
Defective Device 232 232
Grounding Malfunction 193 193
Display or Visual Feedback Problem 175 175
Failure to Power Up 159 159
Scratched Material 155 155
Positioning Failure 139 139
Human-Device Interface Problem 121 121
Use of Device Problem 111 111
Crack 106 106
Mechanical Problem 105 105
Unexpected Shutdown 103 103
Firing Problem 95 97
Continuous Firing 93 93
Fracture 93 93
Poor Quality Image 92 92
Sparking 85 85
Smoking 80 80

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88317 88333
Insufficient Information 20555 20561
Foreign Body In Patient 1729 1730
Unspecified Tissue Injury 1585 1585
Hemorrhage/Blood Loss/Bleeding 1444 1445
Burn(s) 214 214
Bowel Perforation 117 117
Hematoma 100 100
Unspecified Infection 91 92
Cardiac Arrest 91 91
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 90 91
Perforation of Vessels 87 87
No Known Impact Or Consequence To Patient 85 85
Sepsis 69 70
Bacterial Infection 67 67
Fistula 66 67
Failure to Anastomose 64 64
Great Vessel Perforation 62 62
Pain 58 58
Hernia 49 49
Laceration(s) 48 48
Pneumothorax 47 47
Obstruction/Occlusion 43 43
Abdominal Pain 39 40
Abscess 38 38
Pulmonary Embolism 36 36
Seroma 34 34
Low Blood Pressure/ Hypotension 33 33
Thrombosis/Thrombus 33 33
Pneumonia 32 32
Urinary Tract Infection 31 31
Bowel Burn 28 28
Post Operative Wound Infection 28 28
Myocardial Infarction 25 25
Unspecified Gastrointestinal Problem 25 25
Fever 25 25
Perforation 24 24
Pleural Effusion 24 24
Ischemia 23 23
Unspecified Kidney or Urinary Problem 22 22
Device Embedded In Tissue or Plaque 21 21
Unspecified Vascular Problem 21 21
Rectal Anastomotic Leakage 21 21
Necrosis 20 20
Adhesion(s) 19 19
Stroke/CVA 19 19
Bruise/Contusion 19 19
Respiratory Failure 17 17
Nerve Damage 17 17
Respiratory Tract Infection 17 17

Recalls
Manufacturer Recall Class Date Posted
1 Asensus Surgical Inc I Oct-30-2023
2 Intuitive Surgical, Inc. II Jul-10-2026
3 Intuitive Surgical, Inc. II Jun-22-2026
4 Intuitive Surgical, Inc. II Jun-04-2026
5 Intuitive Surgical, Inc. I May-01-2026
6 Intuitive Surgical, Inc. II May-01-2026
7 Intuitive Surgical, Inc. II Mar-30-2026
8 Intuitive Surgical, Inc. II Mar-30-2026
9 Intuitive Surgical, Inc. II Feb-18-2026
10 Intuitive Surgical, Inc. II Feb-12-2026
11 Intuitive Surgical, Inc. II Feb-02-2026
12 Intuitive Surgical, Inc. II Jan-15-2026
13 Intuitive Surgical, Inc. II Dec-19-2025
14 Intuitive Surgical, Inc. II Mar-12-2025
15 Intuitive Surgical, Inc. II Jan-16-2025
16 Intuitive Surgical, Inc. II Jan-10-2025
17 Intuitive Surgical, Inc. II Apr-11-2024
18 Intuitive Surgical, Inc. II Nov-28-2023
19 Intuitive Surgical, Inc. II Jun-30-2023
20 Intuitive Surgical, Inc. II Mar-28-2023
21 Intuitive Surgical, Inc. II Mar-16-2023
22 Intuitive Surgical, Inc. II Nov-30-2022
23 Intuitive Surgical, Inc. II Oct-25-2022
24 Intuitive Surgical, Inc. II Aug-01-2022
25 Intuitive Surgical, Inc. II Jul-25-2022
26 Intuitive Surgical, Inc. II May-31-2022
27 Intuitive Surgical, Inc. II Apr-22-2022
28 Intuitive Surgical, Inc. II Mar-01-2022
29 Intuitive Surgical, Inc. II Dec-27-2021
30 Intuitive Surgical, Inc. II Nov-23-2021
31 Olympus Corporation of the Americas II Jun-28-2024
-
-