TPLC - Total Product Life Cycle

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Device	light, surgical, ceiling mounted
Regulation Description	Surgical lamp.
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	1234	1234
Peeled/Delaminated	857	857
Corroded	317	317
Crack	168	168
Break	84	84
Flaked	78	78
Fluid/Blood Leak	62	62
Mechanical Problem	55	55
No Apparent Adverse Event	54	54
Degraded	54	54
Material Integrity Problem	52	52
Leak/Splash	44	44
Material Erosion	43	43
Fracture	41	41
Material Split, Cut or Torn	34	34
Material Separation	22	22
Insufficient Information	20	20
Grounding Malfunction	18	18
Use of Device Problem	16	16
Device Fell	16	16
Unintended Movement	14	14
Electrical /Electronic Property Problem	11	11
Moisture Damage	10	10
Temperature Problem	8	8
Material Fragmentation	6	6
Overheating of Device	6	6
Radiation Overexposure	5	5
Failure to Clean Adequately	5	5
Output Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Radiation Output Problem	5	5
Unexpected Shutdown	5	5
Pitted	5	5
Appropriate Term/Code Not Available	4	4
Scratched Material	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Smoking	3	3
Naturally Worn	3	3
Contamination /Decontamination Problem	3	3
Excessive Heating	3	3
Device Dislodged or Dislocated	3	3
Unintended Collision	3	3
Loose or Intermittent Connection	2	2
Loss of Power	2	2
Installation-Related Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Handling Problem	2	2
Difficult or Delayed Positioning	2	2
Structural Problem	2	2
Component Missing	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1941	1941
No Consequences Or Impact To Patient	389	389
No Patient Involvement	80	80
No Known Impact Or Consequence To Patient	35	35
Burn(s)	20	20
Insufficient Information	17	17
Full thickness (Third Degree) Burn	10	10
Superficial (First Degree) Burn	5	5
Skin Discoloration	5	5
Concussion	5	5
Laceration(s)	5	5
Partial thickness (Second Degree) Burn	5	5
Bruise/Contusion	5	5
Abrasion	3	3
Foreign Body In Patient	3	3
Erythema	3	3
Scar Tissue	3	3
Injury	2	2
Pain	2	2
Eye Injury	2	2
Skin Tears	2	2
Headache	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hematoma	1	1
Burning Sensation	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1