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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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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 5
INTUITIVE SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 2
INTUITIVE SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 7
  SUBSTANTIALLY EQUIVALENT 14
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 10899 10899
2024 5894 5894

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4323 4323
Break 2567 2567
Visual Prompts will not Clear 2543 2543
Material Fragmentation 2297 2297
Difficult to Open or Close 2295 2295
Material Split, Cut or Torn 1570 1570
Unintended System Motion 1238 1238
Thermal Decomposition of Device 1237 1237
Adverse Event Without Identified Device or Use Problem 1208 1208
Output Problem 1071 1071
Failure to Deliver Energy 1063 1063
Arcing 635 635
No Device Output 625 625
No Apparent Adverse Event 421 421
Insufficient Information 384 384
No Display/Image 379 379
Energy Output Problem 373 373
Material Integrity Problem 337 337
Difficult to Remove 313 313
Unintended Movement 281 281
Defective Device 277 277
Physical Resistance/Sticking 265 265
Device Displays Incorrect Message 258 258
Material Separation 250 250
Material Frayed 250 250
Defective Component 232 232
Failure to Sense 204 204
Entrapment of Device 190 190
Image Orientation Incorrect 186 186
Device Dislodged or Dislocated 182 182
Appropriate Term/Code Not Available 136 136
Mechanical Problem 128 128
Power Problem 120 120
Positioning Failure 108 108
Failure to Cut 100 100
Fracture 86 86
Melted 85 85
Failure to Fire 84 84
Scratched Material 82 82
Material Twisted/Bent 78 78
Crack 77 77
Poor Quality Image 76 76
Failure to Form Staple 62 62
Firing Problem 61 61
Grounding Malfunction 59 59
Sparking 57 57
Smoking 57 57
Use of Device Problem 55 55
Display or Visual Feedback Problem 54 54
Therapeutic or Diagnostic Output Failure 54 54
Failure to Power Up 49 49
Retraction Problem 45 45
Unexpected Shutdown 43 43
Mechanical Jam 41 41
Positioning Problem 40 40
Misfire 38 38
Failure to Calibrate 33 33
Component Missing 30 30
Misfocusing 27 27
Material Discolored 27 27
Noise, Audible 26 26
Intermittent Energy Output 26 26
Dull, Blunt 25 25
Failure to Align 24 24
Loose or Intermittent Connection 24 24
Patient Device Interaction Problem 24 24
Activation Problem 24 24
Optical Discoloration 24 24
Material Protrusion/Extrusion 24 24
Continuous Firing 23 23
Connection Problem 22 22
Optical Problem 22 22
Material Deformation 19 19
Loss of or Failure to Bond 19 19
Device Fell 18 18
Battery Problem 17 17
Difficult or Delayed Activation 16 16
Device Slipped 16 16
Erratic or Intermittent Display 15 15
Mechanics Altered 15 15
Activation Failure 13 13
Electrical /Electronic Property Problem 13 13
Corroded 13 13
Degraded 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
Failure to Seal 11 11
Device Handling Problem 10 10
Difficult to Insert 10 10
Unintended Ejection 10 10
Fogging 9 9
Audible Prompt/Feedback Problem 9 9
Intermittent Loss of Power 8 8
Optical Distortion 8 8
Device Difficult to Setup or Prepare 8 8
Tear, Rip or Hole in Device Packaging 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19860 19860
No Known Impact Or Consequence To Patient 2006 2006
Insufficient Information 1833 1833
Foreign Body In Patient 1257 1257
Hemorrhage/Bleeding 782 782
Unspecified Tissue Injury 590 590
Device Embedded In Tissue or Plaque 323 323
Burn(s) 123 123
Blood Loss 108 108
Injury 106 106
Bowel Perforation 76 76
Perforation of Vessels 63 63
Unspecified Infection 59 59
Death 55 55
Hematoma 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
No Consequences Or Impact To Patient 52 52
Failure to Anastomose 45 45
Pain 44 44
Sepsis 43 43
Cardiac Arrest 36 36
Laceration(s) 36 36
Bowel Burn 32 32
Fistula 30 30
Great Vessel Perforation 26 26
Hernia 26 26
Burn, Thermal 21 21
Tissue Damage 20 20
Abdominal Pain 19 19
No Patient Involvement 19 19
Obstruction/Occlusion 18 18
Thrombosis/Thrombus 17 17
Unspecified Vascular Problem 17 17
Pneumonia 16 16
Pneumothorax 16 16
Bacterial Infection 16 16
Low Blood Pressure/ Hypotension 15 15
Perforation 15 15
Rectal Anastomotic Leakage 15 15
Seroma 14 14
Abscess 14 14
Pulmonary Embolism 14 14
Post Operative Wound Infection 13 13
No Information 13 13
No Code Available 13 13
Bruise/Contusion 12 12
Nerve Damage 12 12
Internal Organ Perforation 11 11
Ischemia 11 11
Necrosis 11 11
Myocardial Infarction 11 11
Fever 11 11
Adhesion(s) 11 11
Urinary Tract Infection 11 11
Unspecified Gastrointestinal Problem 11 11
Liver Laceration(s) 9 9
Anemia 8 8
Wound Dehiscence 7 7
Hypoxia 7 7
Peritonitis 7 7
Fluid Discharge 7 7
Pseudoaneurysm 7 7
Full thickness (Third Degree) Burn 6 6
Heart Failure/Congestive Heart Failure 6 6
Muscle/Tendon Damage 6 6
Unspecified Kidney or Urinary Problem 6 6
Respiratory Tract Infection 6 6
Urinary Retention 6 6
Rupture 6 6
Renal Failure 6 6
Liver Damage/Dysfunction 6 6
Exsanguination 6 6
Atrial Fibrillation 6 6
Stroke/CVA 6 6
Arrhythmia 5 5
Bone Fracture(s) 5 5
Skin Discoloration 5 5
Pulmonary Dysfunction 5 5
Pleural Effusion 5 5
Vomiting 5 5
Numbness 5 5
Low Oxygen Saturation 5 5
Respiratory Failure 5 5
Unspecified Respiratory Problem 5 5
Multiple Organ Failure 5 5
Swelling/ Edema 5 5
Skin Infection 4 4
Vascular Dissection 4 4
Embolism/Embolus 4 4
Impaired Healing 4 4
Swelling 4 4
Septic Shock 4 4
Hypovolemic Shock 4 4
Air Embolism 4 4
Adult Respiratory Distress Syndrome 3 3
Aspiration/Inhalation 3 3
Bradycardia 3 3
Cellulitis 3 3
Hemothorax 3 3
Incontinence 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
27 Olympus Corporation of the Americas II Jun-28-2024
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