TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	30	30
Contamination /Decontamination Problem	18	18
Detachment of Device or Device Component	14	14
Microbial Contamination of Device	11	11
Material Separation	9	9
Fracture	9	9
Insufficient Information	7	7
Mechanical Problem	5	5
Material Integrity Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Leak/Splash	4	4
Chemical Problem	4	4
Peeled/Delaminated	3	3
Device Reprocessing Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Material Deformation	2	2
No Apparent Adverse Event	2	2
Failure to Clean Adequately	2	2
Failure to Conduct	2	2
Material Fragmentation	2	2
Calcified	2	2
Component Missing	2	2
Use of Device Problem	2	2
Optical Problem	2	2
Optical Obstruction	2	2
Device Difficult to Maintain	1	1
Device-Device Incompatibility	1	1
Device Dislodged or Dislocated	1	1
Material Perforation	1	1
Misfocusing	1	1
Blocked Connection	1	1
Material Invagination	1	1
Failure to Power Up	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Contamination	1	1
Corroded	1	1
Crack	1	1
Material Discolored	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Device Handling Problem	1	1
Separation Problem	1	1
Gas/Air Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	59	59
Insufficient Information	33	33
Unspecified Infection	15	15
Bacterial Infection	12	12
Urinary Tract Infection	11	11
Foreign Body In Patient	6	6
Unspecified Kidney or Urinary Problem	4	4
Hemorrhage/Bleeding	3	3
Skin Inflammation/ Irritation	2	2
Post Operative Wound Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Unintended Radiation Exposure	2	2
Intra-Abdominal Hemorrhage	1	1
Bowel Perforation	1	1
Burn(s)	1	1
Fever	1	1
Urinary Retention	1	1
Pain	1	1
Unspecified Hepatic or Biliary Problem	1	1
Pneumonia	1	1
Unspecified Heart Problem	1	1
Bruise/Contusion	1	1