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	1121	1132
Peeled/Delaminated	940	944
Corroded	268	268
Crack	170	170
Fluid/Blood Leak	65	65
No Apparent Adverse Event	55	55
Break	54	54
Flaked	49	49
Fracture	42	42
Material Erosion	42	42
Leak/Splash	34	34
Material Split, Cut or Torn	33	33
Mechanical Problem	32	32
Material Integrity Problem	26	26
Degraded	25	25
Material Separation	20	20
Insufficient Information	20	20
Unintended Movement	15	15
Use of Device Problem	14	14
Device Fell	11	11
Moisture Damage	10	10
Electrical /Electronic Property Problem	9	9
Grounding Malfunction	8	9
Material Fragmentation	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Dislodged or Dislocated	5	5
Unexpected Shutdown	5	5
Failure to Clean Adequately	5	5
Scratched Material	5	5
Appropriate Term/Code Not Available	4	4
Excessive Heating	4	4
Overheating of Device	4	4
Pitted	3	3
Unintended Collision	3	3
Temperature Problem	3	3
Installation-Related Problem	3	3
Naturally Worn	3	3
Defective Component	3	3
Power Problem	2	2
Device Handling Problem	2	2
Off-Label Use	2	2
Structural Problem	2	2
Loose or Intermittent Connection	2	2
Difficult or Delayed Positioning	2	2
Positioning Failure	2	2
Fire	2	2
Loss of or Failure to Bond	1	1
Melted	1	1
Separation Failure	1	1
Device Tipped Over	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2229	2243
No Consequences Or Impact To Patient	77	77
Burn(s)	21	21
Insufficient Information	17	17
Full thickness (Third Degree) Burn	10	10
Partial thickness (Second Degree) Burn	6	6
Superficial (First Degree) Burn	5	5
Concussion	5	5
Pain	5	5
Erythema	4	4
Laceration(s)	4	4
Bruise/Contusion	4	4
Abrasion	3	3
Foreign Body In Patient	3	3
Scar Tissue	3	3
Head Injury	2	2
Eye Injury	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Headache	2	2
Phototoxicity	1	1
Impaired Healing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Wound Dehiscence	1	1
Hematoma	1	1
Burn, Thermal	1	1
Blister	1	1
Skin Discoloration	1	1
No Known Impact Or Consequence To Patient	1	1
Burning Sensation	1	1
No Patient Involvement	1	1
Fall	1	1
Visual Impairment	1	1
Muscle/Tendon Damage	1	1
Swelling/ Edema	1	1
Uveitis	1	1
Distress	1	1