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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.
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 58

Device Problems
Break 268
Device displays error message 65
Detachment of device component 63
Device operates differently than expected 52
Failure to deliver energy 45
Electrical issue 42
No Information 28
Component falling 25
Arcing 24
Material frayed 17
Device or device fragments location unknown 15
No Known Device Problem 15
Difficult to open or close 13
Mechanical issue 12
Failure to power-up 9
Device inoperable 7
Defective component 7
Device Issue 7
Detachment of device or device component 6
Material fragmentation 6
Fracture 5
Energy output to patient tissue incorrect 5
Crack 5
Failure to form staple 5
Torn material 4
Not Applicable 4
Burn of device or device component 4
No device output 4
Failure to sense 3
Hole in material 3
Poor quality image 3
Output issue 3
Misfire 3
Malposition of device 2
Device stops intermittently 2
Component missing 2
Use of Device Issue 2
Mechanical jam 2
Difficult to insert 2
Melted 2
Peeled 2
Loss of power 2
Difficult to remove 2
Failure to Adhere or Bond 2
Degraded 2
No display or display failure 1
Fail-safe design failure 1
Fire 1
Flaked 1
Loss of or failure to bond 1
Computer software issue 1
Calibration error 1
Coagulation in device or device ingredient 1
Self-activation or keying 1
Sensor problems 1
Material separation 1
Slippage of device or device component 1
Image display error 1
No code available 1
Power source issue 1
Protective measure issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Material integrity issue 1
Material twisted 1
Unknown (for use when the device problem is not known) 1
Burn hole(s) 1
Low readings 1
Failure to align 1
Deployment issue 1
Split 1
Failure to separate 1
Defective item 1
Total Device Problems 829

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 2
Class III 0 0 0 0 0 0 1 0 0 0 0

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

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