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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, surgical, computer controlled instrument
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
AKTORMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
ASENSUS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 4
INTUITIVE SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 2
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 7
  SUBSTANTIALLY EQUIVALENT 13
TRANSENTERIX INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSENTERIX, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 1154 1154
2020 1558 1558
2021 1997 1997
2022 5728 5728
2023 10898 10898
2024 2812 2812

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4082 4082
Break 2341 2341
Visual Prompts will not Clear 2289 2289
Difficult to Open or Close 2008 2008
Material Fragmentation 1609 1609
Material Split, Cut or Torn 1388 1388
Adverse Event Without Identified Device or Use Problem 1138 1138
Unintended System Motion 1104 1104
Thermal Decomposition of Device 1091 1091
Failure to Deliver Energy 990 990
Output Problem 932 932
Arcing 599 599
No Device Output 581 581
No Apparent Adverse Event 415 415
No Display/Image 362 362
Insufficient Information 355 355
Material Integrity Problem 300 300
Energy Output Problem 289 289
Defective Device 277 277
Difficult to Remove 270 270
Device Displays Incorrect Message 258 258
Physical Resistance/Sticking 250 250
Material Separation 235 235
Defective Component 231 231
Unintended Movement 229 229
Material Frayed 221 221
Failure to Sense 190 190
Device Dislodged or Dislocated 172 172
Image Orientation Incorrect 156 156
Entrapment of Device 146 146
Appropriate Term/Code Not Available 129 129
Mechanical Problem 126 126
Positioning Failure 106 106
Power Problem 99 99
Failure to Cut 97 97
Melted 84 84
Failure to Fire 82 82
Fracture 78 78
Scratched Material 78 78
Poor Quality Image 75 75
Crack 73 73
Material Twisted/Bent 65 65
Failure to Form Staple 62 62
Sparking 55 55
Firing Problem 55 55
Therapeutic or Diagnostic Output Failure 54 54
Display or Visual Feedback Problem 54 54
Smoking 53 53
Use of Device Problem 50 50
Grounding Malfunction 47 47
Failure to Power Up 46 46
Retraction Problem 45 45
Mechanical Jam 40 40
Unexpected Shutdown 39 39
Misfire 37 37
Failure to Calibrate 31 31
Component Missing 30 30
Positioning Problem 30 30
Misfocusing 27 27
Material Discolored 26 26
Intermittent Energy Output 26 26
Noise, Audible 25 25
Dull, Blunt 25 25
Loose or Intermittent Connection 24 24
Patient Device Interaction Problem 24 24
Optical Discoloration 24 24
Material Protrusion/Extrusion 24 24
Activation Problem 24 24
Failure to Align 23 23
Continuous Firing 21 21
Optical Problem 21 21
Connection Problem 20 20
Loss of or Failure to Bond 19 19
Material Deformation 19 19
Device Fell 18 18
Battery Problem 16 16
Difficult or Delayed Activation 16 16
Mechanics Altered 15 15
Device Slipped 14 14
Corroded 13 13
Erratic or Intermittent Display 13 13
Electrical /Electronic Property Problem 13 13
Degraded 13 13
Activation Failure 13 13
Premature End-of-Life Indicator 12 12
Improper or Incorrect Procedure or Method 12 12
Blocked Connection 12 12
Activation, Positioning or Separation Problem 11 11
Device Sensing Problem 11 11
Failure to Advance 11 11
Difficult to Insert 10 10
Device Handling Problem 10 10
Optical Distortion 8 8
Intermittent Loss of Power 8 8
Audible Prompt/Feedback Problem 8 8
Fogging 8 8
Device Difficult to Setup or Prepare 8 8
Human-Device Interface Problem 8 8
Communication or Transmission Problem 8 8
Electrical Power Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17344 17344
No Known Impact Or Consequence To Patient 2006 2006
Insufficient Information 1603 1603
Foreign Body In Patient 1054 1054
Hemorrhage/Bleeding 726 726
Unspecified Tissue Injury 543 543
Device Embedded In Tissue or Plaque 323 323
Burn(s) 110 110
Blood Loss 108 108
Injury 106 106
Bowel Perforation 72 72
Perforation of Vessels 57 57
Unspecified Infection 56 56
Death 55 55
Hematoma 52 52
No Consequences Or Impact To Patient 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Failure to Anastomose 44 44
Pain 42 42
Sepsis 39 39
Cardiac Arrest 35 35
Laceration(s) 34 34
Bowel Burn 31 31
Fistula 30 30
Great Vessel Perforation 26 26
Hernia 23 23
Burn, Thermal 21 21
Tissue Damage 20 20
No Patient Involvement 19 19
Obstruction/Occlusion 18 18
Unspecified Vascular Problem 17 17
Abdominal Pain 16 16
Perforation 15 15
Low Blood Pressure/ Hypotension 14 14
Abscess 14 14
Seroma 14 14
Pneumonia 14 14
Pneumothorax 14 14
Rectal Anastomotic Leakage 14 14
No Information 13 13
No Code Available 13 13
Post Operative Wound Infection 13 13
Bacterial Infection 12 12
Bruise/Contusion 12 12
Nerve Damage 12 12
Thrombosis/Thrombus 12 12
Internal Organ Perforation 11 11
Myocardial Infarction 11 11
Ischemia 11 11
Necrosis 11 11
Adhesion(s) 11 11
Pulmonary Embolism 10 10
Fever 10 10
Urinary Tract Infection 10 10
Unspecified Gastrointestinal Problem 10 10
Liver Laceration(s) 9 9
Anemia 8 8
Peritonitis 7 7
Pseudoaneurysm 7 7
Full thickness (Third Degree) Burn 6 6
Fluid Discharge 6 6
Heart Failure/Congestive Heart Failure 6 6
Muscle/Tendon Damage 6 6
Unspecified Kidney or Urinary Problem 6 6
Rupture 6 6
Atrial Fibrillation 6 6
Wound Dehiscence 6 6
Stroke/CVA 6 6
Liver Damage/Dysfunction 6 6
Exsanguination 6 6
Hypoxia 6 6
Bone Fracture(s) 5 5
Arrhythmia 5 5
Vomiting 5 5
Pulmonary Dysfunction 5 5
Renal Failure 5 5
Urinary Retention 5 5
Skin Discoloration 5 5
Numbness 5 5
Respiratory Tract Infection 5 5
Low Oxygen Saturation 5 5
Unspecified Respiratory Problem 5 5
Multiple Organ Failure 5 5
Swelling/ Edema 5 5
Embolism/Embolus 4 4
Vascular Dissection 4 4
Skin Infection 4 4
Respiratory Failure 4 4
Impaired Healing 4 4
Swelling 4 4
Pleural Effusion 4 4
Air Embolism 4 4
Hypovolemic Shock 4 4
Hemothorax 3 3
Incontinence 3 3
Infiltration into Tissue 3 3
Muscle Weakness 3 3
Adult Respiratory Distress Syndrome 3 3
Bradycardia 3 3
Septic Shock 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Asensus Surgical Inc I Oct-30-2023
2 Intuitive Surgical Inc II May-05-2020
3 Intuitive Surgical, Inc. II Apr-11-2024
4 Intuitive Surgical, Inc. II Nov-28-2023
5 Intuitive Surgical, Inc. II Jun-30-2023
6 Intuitive Surgical, Inc. II Mar-28-2023
7 Intuitive Surgical, Inc. II Mar-16-2023
8 Intuitive Surgical, Inc. II Nov-30-2022
9 Intuitive Surgical, Inc. II Oct-25-2022
10 Intuitive Surgical, Inc. II Aug-01-2022
11 Intuitive Surgical, Inc. II Jul-25-2022
12 Intuitive Surgical, Inc. II May-31-2022
13 Intuitive Surgical, Inc. II Apr-22-2022
14 Intuitive Surgical, Inc. II Mar-01-2022
15 Intuitive Surgical, Inc. II Dec-27-2021
16 Intuitive Surgical, Inc. II Nov-23-2021
17 Intuitive Surgical, Inc. II Oct-23-2020
18 Intuitive Surgical, Inc. II Jun-03-2020
19 Intuitive Surgical, Inc. II Jun-01-2020
20 Intuitive Surgical, Inc. II May-11-2020
21 Intuitive Surgical, Inc. II May-06-2020
22 Intuitive Surgical, Inc. II Feb-06-2020
23 Intuitive Surgical, Inc. II Jan-31-2020
24 Intuitive Surgical, Inc. II Jan-24-2020
25 Intuitive Surgical, Inc. II Oct-30-2019
26 Intuitive Surgical, Inc. II Feb-15-2019
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