TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	809	809
Vibration	460	460
Physical Resistance/Sticking	104	104
Mechanical Jam	69	69
Material Fragmentation	46	46
Material Separation	42	42
Connection Problem	25	25
Noise, Audible	17	17
Overheating of Device	12	12
Mechanical Problem	10	10
Use of Device Problem	9	9
Material Twisted/Bent	8	8
Device Markings/Labelling Problem	7	7
Output Problem	5	5
Fitting Problem	4	4
Failure to Cut	4	4
Defective Device	3	3
Difficult to Insert	3	3
Dull, Blunt	2	2
Unintended Movement	2	2
Fracture	2	2
Inadequacy of Device Shape and/or Size	2	2
Material Deformation	2	2
No Device Output	1	1
Intermittent Loss of Power	1	1
Failure to Disconnect	1	1
No Apparent Adverse Event	1	1
Detachment of Device or Device Component	1	1
Misconnection	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Mechanics Altered	1	1
Blocked Connection	1	1
Failure to Align	1	1
Failure to Power Up	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Smoking	1	1
Inability to Irrigate	1	1
Collapse	1	1
Suction Failure	1	1
Crack	1	1
Activation Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1283	1283
No Consequences Or Impact To Patient	66	66
Insufficient Information	20	20
No Patient Involvement	11	11
Unintended Radiation Exposure	9	9
Unspecified Tissue Injury	6	6
Device Embedded In Tissue or Plaque	6	6
No Known Impact Or Consequence To Patient	4	4
Radiation Exposure, Unintended	3	3
Bone Fracture(s)	3	3
Foreign Body In Patient	3	3
Oversedation	2	2
Eye Injury	2	2
Superficial (First Degree) Burn	1	1