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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device modular electromechanical surgical system
Definition A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.
Product CodeSCV
Regulation Number 878.4964
Device Class 2


Premarket Reviews
ManufacturerDecision
CMR SURGICAL LIMITED
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 84 84
2026 1276 1276

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes or Fails to Launch 281 281
Communication or Transmission Problem 266 266
Display or Visual Feedback Problem 214 214
Break 209 209
Intermittent Communication Failure 190 190
Difficult to Remove 149 149
Difficult or Delayed Activation 114 114
Failure to Calibrate 87 87
Device Fell 77 77
No Display/Image 58 58
Activation Problem 58 58
Positioning Problem 53 53
Use of Device Problem 38 38
Component or Accessory Incompatibility 36 36
Device Displays Incorrect Message 35 35
Unintended Collision 30 30
Unintended System Motion 30 30
Connection Problem 26 26
Device Alarm System 22 22
Failure to Sense 20 20
Display Difficult to Read 20 20
No Apparent Adverse Event 20 20
Premature Discharge of Battery 19 19
Material Integrity Problem 18 18
Failure to Cut 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Complete Loss of Power 15 15
Insufficient Device Problem Information 12 12
Difficult to Insert 11 11
Fail-Safe Did Not Operate 11 11
Failure to Power Up 10 10
No Tactile Prompts/Feedback 10 10
False Alarm 9 9
Material Twisted/Bent 7 7
Material Split, Cut or Torn 7 7
Delayed Program or Algorithm Execution 7 7
Noise, Audible 6 6
Accessory Incompatible 6 6
Emergency Power Failure 5 5
Mechanical Problem 4 4
Failure to Shut Off 4 4
Battery Problem 4 4
Material Frayed 4 4
Device Reprocessing Problem 4 4
Activation, Positioning or Separation Problem 3 3
Fitting Problem 3 3
Vibration 3 3
Premature End-of-Life Indicator 3 3
Unstable 3 3
Labelling, Instructions for Use or Training Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1300 1300
Insufficient Information 26 26
Hemorrhage/Blood Loss/Bleeding 15 15
Laceration(s) 10 10
Tissue Breakdown 8 8
Unintended Radiation Exposure 6 6
Unspecified Tissue Injury 5 5
Bowel Perforation 4 4
Foreign Body In Patient 4 4
Bowel Burn 2 2
Burn(s) 2 2
Full thickness (Third Degree) Burn 2 2
Discomfort 1 1
Abdominal Pain 1 1
Hematoma 1 1
Ascites 1 1
Electric Shock 1 1
Pulmonary Embolism 1 1
Intra-Abdominal Hemorrhage 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Ecchymosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CMR SURGICAL LIMITED II Jul-09-2026
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