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 Code	SCV
Regulation Number	878.4964
Device Class	2

MDR Year	MDR Reports	MDR Events
2025	84	84

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	23	23
Communication or Transmission Problem	19	19
Break	14	14
Display or Visual Feedback Problem	11	11
Intermittent Communication Failure	11	11
Difficult or Delayed Activation	8	8
Difficult to Remove	7	7
Device Fell	4	4
Positioning Problem	4	4
Unintended Collision	4	4
Component or Accessory Incompatibility	3	3
Activation Problem	3	3
Failure to Calibrate	3	3
No Display/Image	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Ejection Problem	2	2
Use of Device Problem	2	2
Defective Alarm	2	2
Fitting Problem	1	1
Accessory Incompatible	1	1
Display Difficult to Read	1	1
Emergency Power Failure	1	1
Failure to Power Up	1	1
Failure to Cut	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Excessive Heating	1	1
Delayed Program or Algorithm Execution	1	1
Device Displays Incorrect Message	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	78	78
Insufficient Information	4	4
Laceration(s)	2	2
Hemorrhage/Bleeding	1	1