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	1248	1248
Peeled/Delaminated	888	888
Corroded	320	320
Crack	174	174
Break	86	86
Flaked	78	78
Fluid/Blood Leak	65	65
No Apparent Adverse Event	55	55
Mechanical Problem	55	55
Degraded	54	54
Material Integrity Problem	52	52
Leak/Splash	44	44
Material Erosion	43	43
Fracture	42	42
Material Split, Cut or Torn	34	34
Material Separation	23	23
Insufficient Information	20	20
Grounding Malfunction	18	18
Use of Device Problem	18	18
Device Fell	16	16
Unintended Movement	15	15
Electrical /Electronic Property Problem	11	11
Moisture Damage	10	10
Temperature Problem	8	8
Improper or Incorrect Procedure or Method	6	6
Material Fragmentation	6	6
Overheating of Device	6	6
Failure to Clean Adequately	5	5
Radiation Output Problem	5	5
Unexpected Shutdown	5	5
Radiation Overexposure	5	5
Output Problem	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
Contamination /Decontamination Problem	3	3
Excessive Heating	3	3
Device Dislodged or Dislocated	3	3
Smoking	3	3
Naturally Worn	3	3
Unintended Collision	3	3
Component Misassembled	2	2
Device Handling Problem	2	2
Difficult or Delayed Positioning	2	2
Positioning Failure	2	2
Off-Label Use	2	2
Loss of Power	2	2
Loose or Intermittent Connection	2	2
Structural Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1988	1988
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
Skin Discoloration	6	6
Laceration(s)	5	5
Concussion	5	5
Superficial (First Degree) Burn	5	5
Partial thickness (Second Degree) Burn	5	5
Bruise/Contusion	5	5
Pain	3	3
Scar Tissue	3	3
Foreign Body In Patient	3	3
Abrasion	3	3
Erythema	3	3
Injury	2	2
Skin Tears	2	2
Eye Injury	2	2
Headache	2	2
Burning Sensation	1	1
No Code Available	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hematoma	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1