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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 6
  SUBSTANTIALLY EQUIVALENT 42
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 891
Detachment Of Device Component 272
Device Displays Incorrect Message 265
Device Operates Differently Than Expected 213
Failure to Deliver Energy 147
Electrical /Electronic Property Problem 108
Arcing 91
Device Or Device Fragments Location Unknown 87
Insufficient Information 87
Defective Component 66
Difficult to Open or Close 47
Detachment of Device or device Component 36
Device Issue 31
Component Falling 24
No Device Output 23
Poor Quality Image 23
Mechanical Problem 18
Material Frayed 17
Adverse Event Without Identified Device or Use Problem 17
Material Fragmentation 12
No Display / Image 11
Failure to Power Up 10
Use of Device Problem 9
Power Problem 9
Energy Output To Patient Tissue Incorrect 8
Misfire 8
Device Dislodged or Dislocated 7
Failure to Form Staple 7
Fracture 6
Device Inoperable 5
Loss of Power 5
Crack 5
Torn Material 4
Computer Software Problem 4
No Apparent Adverse Event 4
Appropriate Term/Code Not Available 4
Failure to Sense 3
Human-Device Interface Problem 3
Malposition of device 3
Output Problem 3
Hole In Material 3
Mechanical Jam 2
Device Handling Problem 2
Peeled / Delaminated 2
Inadequate User Interface 2
Difficult to Remove 2
Failure To Adhere Or Bond 2
Device Stops Intermittently 2
Degraded 2
Component Missing 2
Failure to Cut 2
Melted 2
Loss of or Failure to Bond 1
Activation, Positioning or Separation 1
Unknown (for use when the device problem is not known) 1
Coagulation in Device or device Ingredient 1
Self-Activation or Keying 1
Electrical Power Problem 1
Low Readings 1
Improper Device Output 1
Material Integrity Problem 1
Bent 1
Fire 1
Communication or Transmission Problem 1
Difficult to Open or Remove Packaging Material 1
Unintended Arm Motion 1
Defective Device 1
Calibration Problem 1
Scratched Material 1
Device Alarm System 1
Thermal Decomposition of Device 1
Calibration Error 1
Flaked 1
Difficult to Insert 1
Failure of Device to Self-Test 1
Unintended Collision 1
Image Display Error / Artifact 1
Material Separation 1
Installation-Related Problem 1
Separation Failure 1
Total Device Problems 2646

Recalls
Manufacturer Recall Class Date Posted
1 Intuitive Surgical, Inc. II Sep-26-2018
2 Intuitive Surgical, Inc. II Sep-12-2018
3 Intuitive Surgical, Inc. II Aug-16-2018
4 Intuitive Surgical, Inc. II Jul-02-2018
5 Intuitive Surgical, Inc. II Jan-23-2018
6 Intuitive Surgical, Inc. II Jun-06-2017
7 Intuitive Surgical, Inc. II Apr-13-2017
8 Intuitive Surgical, Inc. II Apr-05-2017
9 Intuitive Surgical, Inc. II Oct-26-2016
10 Intuitive Surgical, Inc. II Aug-26-2016
11 Intuitive Surgical, Inc. II Aug-05-2016
12 Intuitive Surgical, Inc. II May-27-2016
13 Intuitive Surgical, Inc. II Apr-26-2016
14 Intuitive Surgical, Inc. II Apr-12-2016
15 Intuitive Surgical, Inc. II Mar-18-2016
16 Intuitive Surgical, Inc. II Jan-14-2016
17 Intuitive Surgical, Inc. II Sep-17-2015
18 Intuitive Surgical, Inc. II Sep-10-2015
19 Intuitive Surgical, Inc. II Sep-03-2015
20 Intuitive Surgical, Inc. II Jul-01-2015
21 Intuitive Surgical, Inc. II Jun-17-2015
22 Intuitive Surgical, Inc. II Mar-20-2015
23 Intuitive Surgical, Inc. II Feb-27-2015
24 Intuitive Surgical, Inc. II Feb-24-2015
25 Intuitive Surgical, Inc. II Feb-13-2015
26 Intuitive Surgical, Inc. II Feb-03-2015
27 Intuitive Surgical, Inc. II Jan-07-2015
28 Intuitive Surgical, Inc. II Nov-25-2014
29 Intuitive Surgical, Inc. II Oct-16-2014
30 Intuitive Surgical, Inc. II Oct-10-2014
31 Intuitive Surgical, Inc. II Sep-30-2014
32 Intuitive Surgical, Inc. II Aug-08-2014
33 Intuitive Surgical, Inc. II Jul-08-2014
34 Intuitive Surgical, Inc. II Jul-04-2014
35 Intuitive Surgical, Inc. II Jul-02-2014
36 Intuitive Surgical, Inc. II Jun-25-2014
37 Intuitive Surgical, Inc. II Jun-04-2014
38 Intuitive Surgical, Inc. II Apr-04-2014
39 Intuitive Surgical, Inc. II Dec-16-2013
40 Intuitive Surgical, Inc. II Dec-03-2013
41 Intuitive Surgical, Inc. II Nov-04-2013
42 Intuitive Surgical, Inc. III Nov-04-2013
43 Intuitive Surgical, Inc. II Oct-30-2013
44 Intuitive Surgical, Inc. II Oct-28-2013
45 Intuitive Surgical, Inc. II Jul-11-2013
46 Intuitive Surgical, Inc. II Jun-05-2013
47 Intuitive Surgical, Inc. II May-31-2013
48 Intuitive Surgical, Inc. II May-29-2013
49 Intuitive Surgical, Inc. II May-29-2013
50 Intuitive Surgical, Inc. II May-29-2013
51 Intuitive Surgical, Inc. II May-29-2013
52 Intuitive Surgical, Inc. II May-29-2013
53 Intuitive Surgical, Inc. II Apr-13-2013

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