TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	916	916
Vibration	514	514
Physical Resistance/Sticking	116	116
Mechanical Jam	75	75
Material Fragmentation	62	62
Material Separation	35	35
Connection Problem	28	28
Noise, Audible	20	20
Mechanical Problem	13	13
Overheating of Device	12	12
Failure to Cut	11	11
Use of Device Problem	9	9
Material Twisted/Bent	7	7
Material Protrusion/Extrusion	5	5
Fracture	3	3
Detachment of Device or Device Component	3	3
Material Deformation	3	3
Difficult to Insert	3	3
Unintended Movement	3	3
Fitting Problem	3	3
Material Integrity Problem	2	2
No Display/Image	2	2
Device-Device Incompatibility	2	2
Contamination /Decontamination Problem	1	1
Difficult to Remove	1	1
Contamination	1	1
Failure to Align	1	1
Separation Failure	1	1
Mechanics Altered	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inability to Irrigate	1	1
Misconnection	1	1
Collapse	1	1
Suction Failure	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Crack	1	1
Power Problem	1	1
Off-Label Use	1	1
Failure to Disconnect	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1512	1512
Insufficient Information	33	35
Unintended Radiation Exposure	9	9
Unspecified Tissue Injury	5	5
Foreign Body In Patient	3	3
No Consequences Or Impact To Patient	2	2
Device Embedded In Tissue or Plaque	2	2
Superficial (First Degree) Burn	1	1
Intraoperative Cardiac Valve Injury	1	1
Eye Injury	1	1