TPLC - Total Product Life Cycle

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Device	light, surgical, ceiling mounted
Product Code	FSY
Regulation Number	878.4580
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	1269	1269
Peeled/Delaminated	837	837
Corroded	296	296
Crack	206	206
Degraded	114	114
Flaked	108	108
Break	100	100
Material Integrity Problem	85	85
Mechanical Problem	82	82
Device Fell	52	52
No Apparent Adverse Event	49	49
Fluid/Blood Leak	46	46
Material Erosion	42	42
Leak/Splash	41	41
Material Fragmentation	40	40
Fracture	30	30
Material Split, Cut or Torn	27	27
Material Separation	21	21
Grounding Malfunction	18	18
Use of Device Problem	18	18
Unintended Movement	15	15
Insufficient Information	15	15
Temperature Problem	13	13
Electrical /Electronic Property Problem	11	11
Material Disintegration	9	9
Component Missing	8	8
Moisture Damage	8	8
Device Dislodged or Dislocated	6	6
Radiation Overexposure	5	5
Failure to Clean Adequately	5	5
Output Problem	5	5
Radiation Output Problem	5	5
Contamination /Decontamination Problem	5	5
Pitted	5	5
Improper or Incorrect Procedure or Method	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Loose or Intermittent Connection	5	5
Overheating of Device	5	5
Unexpected Shutdown	5	5
Smoking	4	4
Defective Component	4	4
Installation-Related Problem	4	4
Misassembly During Maintenance/Repair	4	4
Naturally Worn	3	3
Device Handling Problem	3	3
Particulates	3	3
Scratched Material	3	3
Unintended Collision	3	3
Structural Problem	2	2
Loss of Power	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1710	1710
No Consequences Or Impact To Patient	519	519
No Known Impact Or Consequence To Patient	306	306
No Patient Involvement	125	125
Burn(s)	21	21
Insufficient Information	16	16
Injury	8	8
Full thickness (Third Degree) Burn	7	7
Skin Discoloration	5	5
Concussion	5	5
Bruise/Contusion	5	5
Laceration(s)	4	4
Superficial (First Degree) Burn	3	3
Abrasion	3	3
Foreign Body In Patient	3	3
Skin Tears	3	3
Headache	3	3
Patient Problem/Medical Problem	2	2
Head Injury	2	2
Eye Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Burn, Thermal	1	1
Burning Sensation	1	1
Swelling	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1