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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
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 5
  SUBSTANTIALLY EQUIVALENT 44
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Break 1190
Device Displays Incorrect Message 366
Detachment Of Device Component 271
Failure to Deliver Energy 222
Device Operates Differently Than Expected 213
Insufficient Information 156
Defective Component 150
Detachment of Device or device Component 133
Arcing 131
Electrical /Electronic Property Problem 118
Device Or Device Fragments Location Unknown 87
Difficult to Open or Close 56
Poor Quality Image 30
No Device Output 28
Device Issue 28
Adverse Event Without Identified Device or Use Problem 27
Material Fragmentation 26
Component Falling 24
Mechanical Problem 20
No Display / Image 18
Misfire 13
Failure to Power Up 12
Power Problem 12
Material Frayed 11
Use of Device Problem 9
Device Dislodged or Dislocated 8
Energy Output To Patient Tissue Incorrect 8
Appropriate Term/Code Not Available 8
Failure to Form Staple 7
Fracture 6
Computer Software Problem 6
Tip 6
No Apparent Adverse Event 6
Device Inoperable 5
Loss of Power 5
Material Separation 4
Smoking 4
Crack 4
Torn Material 4
Knife 3
Output Problem 3
Melted 3
Hole In Material 3
Failure to Sense 3
Component Missing 3
Human-Device Interface Problem 3
Sparking 3
Malposition of device 3
Calibration Problem 3
Failure to Cut 2
Defective Device 2
Electrical Power Problem 2
Difficult to Remove 2
Device Stops Intermittently 2
Degraded 2
Thermal Decomposition of Device 2
Cable 2
Wire 2
Jaw 2
Failure To Adhere Or Bond 2
Mechanical Jam 2
Optical Discoloration 2
Inadequate User Interface 2
Device Handling Problem 2
Sharp Edges 2
Non Reproducible Results 1
Material Split, Cut or Torn 1
Cannula 1
Device Subassembly 1
Installation-Related Problem 1
Material Integrity Problem 1
Scratched Material 1
Unintended Arm Motion 1
Bent 1
Loss of or Failure to Bond 1
Seal 1
PC (Printed Circuit) Board 1
Cover 1
Device Alarm System 1
Calibration Error 1
Coagulation in Device or device Ingredient 1
Image Display Error / Artifact 1
Loose or Intermittent Connection 1
Fire 1
Flaked 1
Peeled / Delaminated 1
Unintended Collision 1
Unknown (for use when the device problem is not known) 1
Self-Activation or Keying 1
Low Readings 1
Difficult or Delayed Activation 1
Electrical Shorting 1
Failure of Device to Self-Test 1
Improper Device Output 1
Difficult to Open or Remove Packaging Material 1
Communication or Transmission Problem 1
Connection Problem 1
Activation, Positioning or Separation Problem 1
Total Device Problems 3527

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

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