TPLC - Total Product Life Cycle

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Device	endoscope, accessories, image post-processing for color enhancement
Regulation Description	Endoscope and accessories.
Definition	Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Product Code	PEA
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	122	122
Erratic or Intermittent Display	60	60
Unintended Movement	58	58
Optical Problem	48	48
Break	46	46
Product Quality Problem	34	34
Poor Quality Image	31	31
Circuit Failure	18	18
Display or Visual Feedback Problem	11	11
Overheating of Device	11	11
Optical Obstruction	10	10
Data Problem	9	9
Unintended System Motion	8	8
Fluid/Blood Leak	6	6
Device Markings/Labelling Problem	6	6
Failure to Power Up	6	6
Optical Distortion	6	6
Loose or Intermittent Connection	5	5
Optical Discoloration	5	5
Patient Data Problem	5	5
Computer Software Problem	4	4
Obstruction of Flow	4	4
Intermittent Loss of Power	3	3
Connection Problem	3	3
Suction Problem	3	3
Power Problem	3	3
Fracture	3	3
Communication or Transmission Problem	3	3
Unintended Power Up	3	3
Image Display Error/Artifact	3	3
Unstable	2	2
Electrical Overstress	2	2
Device Damaged by Another Device	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Split, Cut or Torn	2	2
Output Problem	2	2
Display Difficult to Read	2	2
Unintended Electrical Shock	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Noise, Audible	1	1
Sparking	1	1
No Flow	1	1
Device Displays Incorrect Message	1	1
Electrical /Electronic Property Problem	1	1
Unexpected Shutdown	1	1
Mechanical Problem	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Self-Activation or Keying	1	1
Incomplete or Inadequate Connection	1	1
Application Network Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	495	495
Insufficient Information	16	16
Electric Shock	2	2
Epistaxis	2	2
Melena	2	2
Burn(s)	2	2
Undesired Nerve Stimulation	2	2
Vomiting	2	2
Distress	1	1