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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 54

Device Problems
Break 102
Component falling 24
Device operates differently than expected 22
Device displays error message 20
Detachment of device component 19
Material frayed 17
No Known Device Problem 14
No Information 10
Electrical issue 9
Failure to deliver energy 9
Device inoperable 7
Arcing 7
Device Issue 6
Device or device fragments location unknown 5
Detachment of device or device component 5
Crack 5
Burn of device or device component 4
Mechanical issue 4
Failure to form staple 4
Not Applicable 4
Torn material 3
Difficult to open or close 3
Failure to power-up 3
Hole in material 3
Fracture 3
Material fragmentation 3
Degraded 2
Failure to Adhere or Bond 2
Difficult to remove 2
Difficult to insert 2
No device output 2
Device stops intermittently 2
Component missing 2
Mechanical jam 2
Malposition of device 2
Output issue 2
Protective measure issue 1
No code available 1
Deployment issue 1
Material integrity issue 1
Material twisted 1
Defective item 1
Low readings 1
Failure to align 1
Split 1
Failure to separate 1
Peeled 1
Loss of power 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Burn hole(s) 1
Melted 1
Poor quality image 1
Self-activation or keying 1
Failure to sense 1
Sensor problems 1
Material separation 1
Slippage of device or device component 1
Loss of or failure to bond 1
Calibration error 1
Coagulation in device or device ingredient 1
Image display error 1
Fail-safe design failure 1
Fire 1
Flaked 1
Total Device Problems 365

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

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

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