TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Energy Output Problem	184	184
Adverse Event Without Identified Device or Use Problem	57	57
Appropriate Term/Code Not Available	44	44
Failure to Deliver Energy	24	24
Power Problem	24	24
Failure to Fire	22	22
Unexpected Shutdown	16	16
Electrical /Electronic Property Problem	10	10
Intermittent Energy Output	10	10
Therapeutic or Diagnostic Output Failure	10	10
Loss of Power	8	8
Unexpected Therapeutic Results	8	8
Use of Device Problem	8	8
Output Problem	7	7
Firing Problem	7	7
Break	6	6
Insufficient Information	6	6
Self-Activation or Keying	6	6
Defective Component	6	6
Display or Visual Feedback Problem	5	5
Output below Specifications	4	4
No Display/Image	4	4
Device Operational Issue	4	4
Inappropriate or Unexpected Reset	4	4
Misfocusing	3	3
Patient-Device Incompatibility	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Noise, Audible	2	2
Intermittent Loss of Power	2	2
Improper or Incorrect Procedure or Method	2	2
Connection Problem	2	2
Device Handling Problem	2	2
Failure to Align	2	2
Component Missing	2	2
Failure to Power Up	2	2
Energy Spectrum Incorrect	1	1
No Audible Prompt/Feedback	1	1
Program or Algorithm Execution Problem	1	1
Device Emits Odor	1	1
Power Conditioning Problem	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Contamination with Chemical or Other Material	1	1
Component Misassembled	1	1
Misfire	1	1
Key or Button Unresponsive/not Working	1	1
Intermittent Continuity	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	233	233
No Known Impact Or Consequence To Patient	58	58
Insufficient Information	51	51
Eye Burn	39	39
No Consequences Or Impact To Patient	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Eye Injury	13	13
No Patient Involvement	8	8
Visual Impairment	8	8
Superficial (First Degree) Burn	6	6
No Code Available	5	5
Hemorrhage/Bleeding	5	5
Keratitis	5	5
Blurred Vision	4	4
Eye Pain	3	3
Intraocular Pressure Increased	3	3
Cataract	3	3
Retinal Injury	3	3
Vitreous Hemorrhage	3	3
Loss of Vision	2	2
Flashers	2	2
Pain	2	2
Intraocular Pressure Decreased	1	1
Partial thickness (Second Degree) Burn	1	1
Tissue Damage	1	1
Vitreous Floaters	1	1
Swelling/ Edema	1	1
Corneal Edema	1	1
Unspecified Eye / Vision Problem	1	1
Nerve Damage	1	1
Burning Sensation	1	1
Visual Disturbances	1	1
Glaucoma	1	1
Cardiac Arrest	1	1
Heart Failure	1	1
Perforation	1	1
Dry Eye(s)	1	1
No Information	1	1
Radiation Exposure, Unintended	1	1
Red Eye(s)	1	1
Hypersensitivity/Allergic reaction	1	1