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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 51

Device Problems
Break 52
Component falling 23
Material frayed 17
Device operates differently than expected 17
Detachment of device component 16
Device displays error message 13
No Known Device Problem 9
No Information 8
Device inoperable 7
Device Issue 6
Crack 5
Burn of device or device component 4
Arcing 4
Failure to power-up 3
Hole in material 3
Fracture 3
Material fragmentation 2
Difficult to insert 2
Failure to Adhere or Bond 2
Degraded 2
Failure to deliver energy 2
Difficult to remove 2
Device stops intermittently 2
Mechanical jam 2
Torn material 2
Malposition of device 2
Failure to form staple 2
Detachment of device or device component 2
Deployment issue 1
Difficult to open or close 1
Material integrity issue 1
Material twisted 1
Protective measure issue 1
Defective item 1
Device or device fragments location unknown 1
Low readings 1
Failure to align 1
Split 1
Failure to separate 1
Self-activation or keying 1
Sensor problems 1
Material separation 1
Slippage of device or device component 1
Unknown (for use when the device problem is not known) 1
Burn hole(s) 1
Component missing 1
Fail-safe design failure 1
Fire 1
Loss of or failure to bond 1
Coagulation in device or device ingredient 1
Mechanical issue 1
Melted 1
Poor quality image 1
Peeled 1
Image display error 1
Total Device Problems 241

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 5
Class III 0 0 0 0 0 0 1 0 0 0

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

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