TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	427	427
Material Separation	146	146
Vibration	139	139
Material Fragmentation	93	93
Mechanical Jam	24	24
Overheating of Device	21	21
Physical Resistance/Sticking	16	16
Use of Device Problem	15	15
Connection Problem	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Device Markings/Labelling Problem	9	9
Mechanical Problem	9	9
Noise, Audible	7	7
Contamination /Decontamination Problem	6	6
Output Problem	5	5
Inability to Irrigate	5	5
Material Twisted/Bent	5	5
Unintended Movement	5	5
Loose or Intermittent Connection	3	3
Detachment of Device or Device Component	3	3
Obstruction of Flow	3	3
Defective Device	3	3
Fitting Problem	2	2
Failure to Power Up	2	2
Fracture	2	2
Unstable	2	2
No Apparent Adverse Event	2	2
Intermittent Loss of Power	1	1
Activation Problem	1	1
Self-Activation or Keying	1	1
Inadequacy of Device Shape and/or Size	1	1
Smoking	1	1
Stretched	1	1
Device Inoperable	1	1
Misconnection	1	1
No Device Output	1	1
Complete Blockage	1	1
Crack	1	1
Display or Visual Feedback Problem	1	1
Defective Component	1	1
Dull, Blunt	1	1
Blocked Connection	1	1
Device Operates Differently Than Expected	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	408	408
No Consequences Or Impact To Patient	340	340
No Known Impact Or Consequence To Patient	51	51
No Patient Involvement	21	21
Radiation Exposure, Unintended	10	10
Device Embedded In Tissue or Plaque	7	7
Burn(s)	7	7
Insufficient Information	7	7
Unintended Radiation Exposure	6	6
Foreign Body In Patient	6	6
Abrasion	5	5
Unspecified Tissue Injury	3	3
Bone Fracture(s)	3	3
Hearing Impairment	2	2
Oversedation	2	2
Eye Injury	2	2
Burn, Thermal	1	1
Partial thickness (Second Degree) Burn	1	1
No Information	1	1
No Code Available	1	1