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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
COMPUTER MOTIO
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 7
  SUBSTANTIALLY EQUIVALENT 69

Device Problems
Break 539
Detachment of device component 161
Device displays error message 131
Device operates differently than expected 117
Failure to deliver energy 82
Electrical issue 78
Arcing 52
No Information 50
Device or device fragments location unknown 49
Component falling 30
Difficult to open or close 28
Defective component 24
Device Issue 17
No Known Device Problem 17
Material frayed 17
Mechanical issue 17
Poor quality image 15
No device output 10
Failure to power-up 10
Detachment of device or device component 8
Material fragmentation 8
Energy output to patient tissue incorrect 8
Device inoperable 7
Misfire 6
Fracture 6
Power source issue 6
Torn material 6
Crack 5
Failure to form staple 5
Use of Device Issue 5
Loss of power 4
Dislodged or dislocated 4
Burn of device or device component 4
Hole in material 4
Not Applicable 4
Failure to sense 3
Computer software issue 3
Malposition of device 3
Output issue 3
Human-Device Interface Issue 3
Inadequate user interface 2
Device stops intermittently 2
Difficult to remove 2
Component missing 2
Failure to Adhere or Bond 2
Degraded 2
No display or display failure 2
Peeled 2
Difficult to insert 2
Melted 2
Mechanical jam 2
No code available 1
Device handling issue 1
Protective measure issue 1
Scratched material 1
Image display error 1
Device alarm system issue 1
Unintended collision 1
Sensor problems 1
Material separation 1
Slippage of device or device component 1
Fail-safe design failure 1
Fire 1
Flaked 1
Unintended arm motion 1
Loss of or failure to bond 1
Calibration error 1
Coagulation in device or device ingredient 1
Failure to cut 1
Defective item 1
Split 1
Failure to separate 1
Low readings 1
Failure to align 1
Self-activation or keying 1
Unknown (for use when the device problem is not known) 1
Burn hole(s) 1
Installation-related problem 1
Material integrity issue 1
Material twisted 1
Improper device output 1
Deployment issue 1
Failure of device to self-test 1
Difficult to open or remove packaging material 1
Total Device Problems 1604

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 4 9 0 1 1 3 14 11 11 8 3
Class III 0 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Intuitive Surgical, Inc. II Jun-06-2017
2 Intuitive Surgical, Inc. II Apr-13-2017
3 Intuitive Surgical, Inc. II Apr-05-2017
4 Intuitive Surgical, Inc. II Oct-26-2016
5 Intuitive Surgical, Inc. II Aug-26-2016
6 Intuitive Surgical, Inc. II Aug-05-2016
7 Intuitive Surgical, Inc. II May-27-2016
8 Intuitive Surgical, Inc. II Apr-26-2016
9 Intuitive Surgical, Inc. II Apr-12-2016
10 Intuitive Surgical, Inc. II Mar-18-2016
11 Intuitive Surgical, Inc. II Jan-14-2016
12 Intuitive Surgical, Inc. II Sep-17-2015
13 Intuitive Surgical, Inc. II Sep-10-2015
14 Intuitive Surgical, Inc. II Sep-03-2015
15 Intuitive Surgical, Inc. II Jul-01-2015
16 Intuitive Surgical, Inc. II Jun-17-2015
17 Intuitive Surgical, Inc. II Mar-20-2015
18 Intuitive Surgical, Inc. II Feb-27-2015
19 Intuitive Surgical, Inc. II Feb-24-2015
20 Intuitive Surgical, Inc. II Feb-13-2015
21 Intuitive Surgical, Inc. II Feb-03-2015
22 Intuitive Surgical, Inc. II Jan-07-2015
23 Intuitive Surgical, Inc. II Nov-25-2014
24 Intuitive Surgical, Inc. II Oct-16-2014
25 Intuitive Surgical, Inc. II Oct-10-2014
26 Intuitive Surgical, Inc. II Sep-30-2014
27 Intuitive Surgical, Inc. II Aug-08-2014
28 Intuitive Surgical, Inc. II Jul-08-2014
29 Intuitive Surgical, Inc. II Jul-04-2014
30 Intuitive Surgical, Inc. II Jul-02-2014
31 Intuitive Surgical, Inc. II Jun-25-2014
32 Intuitive Surgical, Inc. II Jun-04-2014
33 Intuitive Surgical, Inc. II Apr-04-2014
34 Intuitive Surgical, Inc. II Dec-16-2013
35 Intuitive Surgical, Inc. II Dec-03-2013
36 Intuitive Surgical, Inc. II Nov-04-2013
37 Intuitive Surgical, Inc. III Nov-04-2013
38 Intuitive Surgical, Inc. II Oct-30-2013
39 Intuitive Surgical, Inc. II Oct-28-2013
40 Intuitive Surgical, Inc. II Jul-11-2013
41 Intuitive Surgical, Inc. II Jun-05-2013
42 Intuitive Surgical, Inc. II May-31-2013
43 Intuitive Surgical, Inc. II May-29-2013
44 Intuitive Surgical, Inc. II May-29-2013
45 Intuitive Surgical, Inc. II May-29-2013
46 Intuitive Surgical, Inc. II May-29-2013
47 Intuitive Surgical, Inc. II May-29-2013
48 Intuitive Surgical, Inc. II Apr-13-2013
49 Intuitive Surgical, Inc. II Sep-10-2012
50 Intuitive Surgical, Inc. II Jul-27-2012
51 Intuitive Surgical, Inc. II Mar-13-2012
52 Intuitive Surgical, Inc. II Aug-03-2011
53 Intuitive Surgical, Inc. II Apr-05-2010
54 Intuitive Surgical, Inc. II Sep-17-2008
55 Intuitive Surgical, Inc. II Sep-16-2008
56 Intuitive Surgical, Inc. II Aug-06-2008
57 Intuitive Surgical, Inc. II Jun-12-2008
58 Intuitive Surgical, Inc. II Feb-22-2008
59 Intuitive Surgical, Inc. II Feb-21-2008
60 Intuitive Surgical, Inc. II Jan-31-2008
61 Intuitive Surgical, Inc. II Jan-31-2008
62 Intuitive Surgical, Inc. II Jan-24-2008
63 Intuitive Surgical, Inc. II Sep-26-2007
64 Intuitive Surgical, Inc. II Sep-26-2007
65 Intuitive Surgical, Inc. II Mar-29-2007
66 Intuitive Surgical, Inc. II Mar-28-2007

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