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).
| Device Type ID | 5459 |
| Device Name | System, Surgical, Computer Controlled Instrument |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NAY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5459 |
| Device | System, Surgical, Computer Controlled Instrument |
| Product Code | NAY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTUITIVE SURGICAL, INC. | ||
SE - WITH LIMITATIONS | 5 | |
SUBSTANTIALLY EQUIVALENT | 43 | |
TRANSENTERIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Break | 1054 |
Device Displays Incorrect Message | 325 |
Detachment Of Device Component | 271 |
Device Operates Differently Than Expected | 213 |
Failure To Deliver Energy | 199 |
Insufficient Information | 129 |
Electrical /Electronic Property Problem | 115 |
Defective Component | 114 |
Arcing | 110 |
Device Or Device Fragments Location Unknown | 87 |
Detachment Of Device Or Device Component | 68 |
Difficult To Open Or Close | 52 |
Poor Quality Image | 29 |
Device Issue | 28 |
No Device Output | 27 |
Component Falling | 24 |
Adverse Event Without Identified Device Or Use Problem | 24 |
Mechanical Problem | 19 |
Material Fragmentation | 15 |
No Display / Image | 13 |
Material Frayed | 11 |
Power Problem | 11 |
Failure To Power Up | 11 |
Misfire | 10 |
Use Of Device Problem | 9 |
Device Dislodged Or Dislocated | 8 |
Energy Output To Patient Tissue Incorrect | 8 |
Failure To Form Staple | 7 |
Fracture | 6 |
Tip | 6 |
Appropriate Term/Code Not Available | 6 |
No Apparent Adverse Event | 5 |
Device Inoperable | 5 |
Loss Of Power | 5 |
Computer Software Problem | 5 |
Crack | 4 |
Torn Material | 4 |
Knife | 3 |
Output Problem | 3 |
Calibration Problem | 3 |
Malposition Of Device | 3 |
Hole In Material | 3 |
Failure To Sense | 3 |
Human-Device Interface Problem | 3 |
Difficult To Remove | 2 |
Cable | 2 |
Failure To Adhere Or Bond | 2 |
Device Stops Intermittently | 2 |
Degraded | 2 |
Component Missing | 2 |
Failure To Cut | 2 |
Melted | 2 |
Wire | 2 |
Jaw | 2 |
Mechanical Jam | 2 |
Device Handling Problem | 2 |
Sharp Edges | 2 |
Inadequate User Interface | 2 |
Difficult To Open Or Remove Packaging Material | 1 |
Defective Device | 1 |
Unintended Arm Motion | 1 |
Scratched Material | 1 |
Device Alarm System | 1 |
Thermal Decomposition Of Device | 1 |
Calibration Error | 1 |
Flaked | 1 |
Loose Or Intermittent Connection | 1 |
Difficult Or Delayed Activation | 1 |
Installation-Related Problem | 1 |
Material Separation | 1 |
Unintended Collision | 1 |
Peeled / Delaminated | 1 |
Image Display Error / Artifact | 1 |
Failure Of Device To Self-Test | 1 |
Device Subassembly | 1 |
Cover | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Self-Activation Or Keying | 1 |
Cannula | 1 |
Electrical Power Problem | 1 |
Smoking | 1 |
Seal | 1 |
Loss Of Or Failure To Bond | 1 |
Activation, Positioning Or Separation Problem | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Low Readings | 1 |
Improper Device Output | 1 |
Material Integrity Problem | 1 |
PC (Printed Circuit) Board | 1 |
Bent | 1 |
Fire | 1 |
Sparking | 1 |
Communication Or Transmission Problem | 1 |
Optical Discoloration | 1 |
| Total Device Problems | 3122 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Intuitive Surgical, Inc. | II | Feb-15-2019 |
| 2 | Intuitive Surgical, Inc. | II | Sep-26-2018 |
| 3 | Intuitive Surgical, Inc. | II | Sep-12-2018 |
| 4 | Intuitive Surgical, Inc. | II | Aug-16-2018 |
| 5 | Intuitive Surgical, Inc. | II | Jul-02-2018 |
| 6 | Intuitive Surgical, Inc. | II | Jan-23-2018 |
| 7 | Intuitive Surgical, Inc. | II | Jun-06-2017 |
| 8 | Intuitive Surgical, Inc. | II | Apr-13-2017 |
| 9 | Intuitive Surgical, Inc. | II | Apr-05-2017 |
| 10 | Intuitive Surgical, Inc. | II | Oct-26-2016 |
| 11 | Intuitive Surgical, Inc. | II | Aug-26-2016 |
| 12 | Intuitive Surgical, Inc. | II | Aug-05-2016 |
| 13 | Intuitive Surgical, Inc. | II | May-27-2016 |
| 14 | Intuitive Surgical, Inc. | II | Apr-26-2016 |
| 15 | Intuitive Surgical, Inc. | II | Apr-12-2016 |
| 16 | Intuitive Surgical, Inc. | II | Mar-18-2016 |
| 17 | Intuitive Surgical, Inc. | II | Jan-14-2016 |
| 18 | Intuitive Surgical, Inc. | II | Sep-17-2015 |
| 19 | Intuitive Surgical, Inc. | II | Sep-10-2015 |
| 20 | Intuitive Surgical, Inc. | II | Sep-03-2015 |
| 21 | Intuitive Surgical, Inc. | II | Jul-01-2015 |
| 22 | Intuitive Surgical, Inc. | II | Jun-17-2015 |
| 23 | Intuitive Surgical, Inc. | II | Mar-20-2015 |
| 24 | Intuitive Surgical, Inc. | II | Feb-27-2015 |
| 25 | Intuitive Surgical, Inc. | II | Feb-24-2015 |
| 26 | Intuitive Surgical, Inc. | II | Feb-13-2015 |
| 27 | Intuitive Surgical, Inc. | II | Feb-03-2015 |
| 28 | Intuitive Surgical, Inc. | II | Jan-07-2015 |
| 29 | Intuitive Surgical, Inc. | II | Nov-25-2014 |
| 30 | Intuitive Surgical, Inc. | II | Oct-16-2014 |
| 31 | Intuitive Surgical, Inc. | II | Oct-10-2014 |
| 32 | Intuitive Surgical, Inc. | II | Sep-30-2014 |
| 33 | Intuitive Surgical, Inc. | II | Aug-08-2014 |
| 34 | Intuitive Surgical, Inc. | II | Jul-08-2014 |
| 35 | Intuitive Surgical, Inc. | II | Jul-04-2014 |
| 36 | Intuitive Surgical, Inc. | II | Jul-02-2014 |
| 37 | Intuitive Surgical, Inc. | II | Jun-25-2014 |
| 38 | Intuitive Surgical, Inc. | II | Jun-04-2014 |
| 39 | Intuitive Surgical, Inc. | II | Apr-04-2014 |