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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 2
  SUBSTANTIALLY EQUIVALENT 43
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Break 1619
Device Displays Incorrect Message 469
Detachment of Device or Device Component 306
Failure to Deliver Energy 293
Detachment Of Device Component 269
Arcing 265
Insufficient Information 228
Defective Component 218
Device Operates Differently Than Expected 212
Electrical /Electronic Property Problem 121
Adverse Event Without Identified Device or Use Problem 92
Device Or Device Fragments Location Unknown 87
Material Fragmentation 86
Thermal Decomposition of Device 78
Difficult to Open or Close 69
No Display/Image 35
Melted 35
Device Dislodged or Dislocated 35
Poor Quality Image 33
No Device Output 28
Device Issue 27
Component Falling 23
Mechanical Problem 22
Misfire 15
Power Problem 13
Failure to Power Up 12
Use of Device Problem 11
Crack 9
Degraded 9
Appropriate Term/Code Not Available 8
Energy Output To Patient Tissue Incorrect 8
Smoking 8
Failure to Form Staple 7
Computer Software Problem 6
Energy Output Problem 6
Fracture 6
No Apparent Adverse Event 6
Material Frayed 6
Component Missing 5
Loss of Power 5
Tip 4
Torn Material 4
Material Separation 4
Defective Device 4
Difficult to Remove 4
Device Inoperable 4
Electrical Shorting 4
Activation Problem 3
Loose or Intermittent Connection 3
Calibration Problem 3
Display or Visual Feedback Problem 3
Hole In Material 3
Sparking 3
Output Problem 3
Human-Device Interface Problem 3
Failure to Cut 3
Electrical Power Problem 3
Failure to Sense 3
Device Fell 3
Device Handling Problem 2
Knife 2
Device Stops Intermittently 2
Failure To Adhere Or Bond 2
Failure to Fire 2
Device Slipped 2
Inadequate User Interface 2
Optical Discoloration 2
Material Split, Cut or Torn 2
Entrapment of Device 2
Sharp Edges 2
Malposition of Device 2
Migration 1
Erratic or Intermittent Display 1
Non Reproducible Results 1
Device Subassembly 1
Connection Problem 1
Activation, Positioning or SeparationProblem 1
Flaked 1
Cable, Electrical 1
Seal 1
Unintended Arm Motion 1
Difficult to Open or Remove Packaging Material 1
Scratched Material 1
Cannula 1
Unintended Collision 1
Low Readings 1
Difficult or Delayed Activation 1
Coagulation in Device or Device Ingredient 1
Self-Activation or Keying 1
Unintended System Motion 1
Jaw 1
Failure of Device to Self-Test 1
Improper Device Output 1
Cover 1
Calibration Error 1
Installation-Related Problem 1
Mechanical Jam 1
Device Damaged by Another Device 1
Arcing of Electrodes 1
Peeled/Delaminated 1
Total Device Problems 4907

Recalls
Manufacturer Recall Class Date Posted
1 Intuitive Surgical Inc II May-05-2020
2 Intuitive Surgical, Inc. II Jun-03-2020
3 Intuitive Surgical, Inc. II Jun-01-2020
4 Intuitive Surgical, Inc. II May-11-2020
5 Intuitive Surgical, Inc. II May-06-2020
6 Intuitive Surgical, Inc. II Feb-06-2020
7 Intuitive Surgical, Inc. II Jan-31-2020
8 Intuitive Surgical, Inc. II Jan-24-2020
9 Intuitive Surgical, Inc. II Oct-30-2019
10 Intuitive Surgical, Inc. II Feb-15-2019
11 Intuitive Surgical, Inc. II Sep-26-2018
12 Intuitive Surgical, Inc. II Sep-12-2018
13 Intuitive Surgical, Inc. II Aug-16-2018
14 Intuitive Surgical, Inc. II Jul-02-2018
15 Intuitive Surgical, Inc. II Jan-23-2018
16 Intuitive Surgical, Inc. II Jun-06-2017
17 Intuitive Surgical, Inc. II Apr-13-2017
18 Intuitive Surgical, Inc. II Apr-05-2017
19 Intuitive Surgical, Inc. II Oct-26-2016
20 Intuitive Surgical, Inc. II Aug-26-2016
21 Intuitive Surgical, Inc. II Aug-05-2016
22 Intuitive Surgical, Inc. II May-27-2016
23 Intuitive Surgical, Inc. II Apr-26-2016
24 Intuitive Surgical, Inc. II Apr-12-2016
25 Intuitive Surgical, Inc. II Mar-18-2016
26 Intuitive Surgical, Inc. II Jan-14-2016
27 Intuitive Surgical, Inc. II Sep-17-2015
28 Intuitive Surgical, Inc. II Sep-10-2015
29 Intuitive Surgical, Inc. II Sep-03-2015
30 Intuitive Surgical, Inc. II Jul-01-2015
31 Intuitive Surgical, Inc. II Jun-17-2015
32 Intuitive Surgical, Inc. II Mar-20-2015
33 Intuitive Surgical, Inc. II Feb-27-2015
34 Intuitive Surgical, Inc. II Feb-24-2015
35 Intuitive Surgical, Inc. II Feb-13-2015
36 Intuitive Surgical, Inc. II Feb-03-2015
37 Intuitive Surgical, Inc. II Jan-07-2015

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