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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 4
  SUBSTANTIALLY EQUIVALENT 43
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Break 1031
Device Displays Incorrect Message 312
Detachment Of Device Component 271
Device Operates Differently Than Expected 213
Failure to Deliver Energy 191
Insufficient Information 123
Electrical /Electronic Property Problem 115
Defective Component 104
Arcing 104
Device Or Device Fragments Location Unknown 87
Detachment of Device or device Component 64
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 22
Mechanical Problem 19
Material Fragmentation 15
No Display / Image 12
Material Frayed 11
Power Problem 11
Failure to Power Up 11
Misfire 9
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 5
Device Inoperable 5
Loss of Power 5
Computer Software Problem 5
Crack 4
Torn Material 4
No Apparent Adverse Event 4
Failure to Sense 3
Human-Device Interface Problem 3
Knife 3
Output Problem 3
Calibration Problem 3
Malposition of device 3
Hole In Material 3
Mechanical Jam 2
Device Handling Problem 2
Sharp Edges 2
Inadequate User Interface 2
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
Coagulation in Device or device Ingredient 1
Self-Activation or Keying 1
Cannula 1
Electrical Power Problem 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
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
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
Total Device Problems 3043

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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