TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	930	930
Vibration	286	286
Material Fragmentation	262	262
Material Separation	152	152
Physical Resistance/Sticking	75	75
Overheating of Device	47	47
Mechanical Jam	45	45
Adverse Event Without Identified Device or Use Problem	24	24
Connection Problem	18	18
Use of Device Problem	16	16
Mechanical Problem	14	14
Noise, Audible	11	11
Fracture	10	10
Device Markings/Labelling Problem	9	9
Material Twisted/Bent	6	6
Contamination /Decontamination Problem	6	6
Stretched	6	6
Unintended Movement	6	6
Inability to Irrigate	6	6
Unintended System Motion	5	5
Output Problem	5	5
Material Deformation	5	5
Device Operates Differently Than Expected	5	5
Detachment Of Device Component	5	5
Detachment of Device or Device Component	4	4
Component Falling	4	4
Fitting Problem	4	4
Defective Device	3	3
Complete Blockage	3	3
Loose or Intermittent Connection	3	3
Device Inoperable	3	3
Obstruction of Flow	3	3
Smoking	2	2
Material Integrity Problem	2	2
Thermal Decomposition of Device	2	2
Inadequacy of Device Shape and/or Size	2	2
No Apparent Adverse Event	2	2
Off-Label Use	2	2
Failure to Power Up	2	2
Dull, Blunt	2	2
Contamination	2	2
Unstable	2	2
Leak/Splash	2	2
Device Appears to Trigger Rejection	1	1
Unexpected Therapeutic Results	1	1
Suction Problem	1	1
Naturally Worn	1	1
Failure to Disconnect	1	1
Display or Visual Feedback Problem	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	877	877
No Consequences Or Impact To Patient	543	543
No Known Impact Or Consequence To Patient	179	179
No Patient Involvement	27	27
Foreign Body In Patient	25	25
Radiation Exposure, Unintended	23	23
Device Embedded In Tissue or Plaque	13	13
Unintended Radiation Exposure	8	8
No Code Available	8	8
Burn(s)	8	8
Insufficient Information	7	7
Tissue Damage	5	5
Unspecified Tissue Injury	5	5
Abrasion	5	5
No Information	5	5
Burn, Thermal	4	4
Hemorrhage/Bleeding	4	4
Injury	3	3
Bone Fracture(s)	3	3
Oversedation	2	2
Eye Injury	2	2
Cerebrospinal Fluid Leakage	2	2
Partial thickness (Second Degree) Burn	2	2
Low Oxygen Saturation	2	2
Superficial (First Degree) Burn	2	2
Hearing Impairment	2	2
Cellulitis	1	1
Perforation	1	1
Exsanguination	1	1
Nerve Damage	1	1
Swelling	1	1
Vertigo	1	1
Hemostasis	1	1
Nasal Obstruction	1	1
Shaking/Tremors	1	1
Pneumothorax	1	1
Feeding Problem	1	1
Discharge	1	1
Skin Tears	1	1
Unspecified Infection	1	1
Headache	1	1