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
2026	123	123

Device Problems	MDRs with this Device Problem	Events in those MDRs
Communication or Transmission Problem	44	44
Break	41	41
Application Program Freezes, Becomes Nonfunctional	41	41
Intermittent Communication Failure	32	32
Display or Visual Feedback Problem	27	27
Difficult to Remove	25	25
Difficult or Delayed Activation	22	22
Device Fell	19	19
Failure to Calibrate	15	15
Positioning Problem	13	13
Unintended Collision	6	6
Component or Accessory Incompatibility	6	6
No Display/Image	6	6
Activation Problem	6	6
No Apparent Adverse Event	5	5
Device Displays Incorrect Message	4	4
Use of Device Problem	4	4
Material Split, Cut or Torn	3	3
Noise, Audible	2	2
Delayed Program or Algorithm Execution	2	2
No Tactile Prompts/Feedback	2	2
Connection Problem	2	2
Unintended System Motion	2	2
Defective Alarm	2	2
Failure to Power Up	2	2
Ejection Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Fail-Safe Did Not Operate	2	2
Accessory Incompatible	2	2
Material Twisted/Bent	1	1
Failure to Cut	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Difficult to Insert	1	1
Appropriate Term/Code Not Available	1	1
Excessive Heating	1	1
Failure to Sense	1	1
Separation Failure	1	1
Emergency Power Failure	1	1
Display Difficult to Read	1	1
Device Alarm System	1	1
Fitting Problem	1	1
Unstable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	198	198
Insufficient Information	6	6
Laceration(s)	3	3
Hemorrhage/Bleeding	2	2