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	1126	1137
Peeled/Delaminated	947	951
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	16	16
Use of Device Problem	14	14
Device Fell	11	11
Moisture Damage	10	10
Electrical /Electronic Property Problem	9	9
Grounding Malfunction	8	9
Adverse Event Without Identified Device or Use Problem	6	6
Material Fragmentation	6	6
Overheating of Device	5	5
Device Dislodged or Dislocated	5	5
Scratched Material	5	5
Failure to Clean Adequately	5	5
Unexpected Shutdown	5	5
Excessive Heating	4	4
Appropriate Term/Code Not Available	4	4
Temperature Problem	3	3
Unintended Collision	3	3
Defective Component	3	3
Pitted	3	3
Naturally Worn	3	3
Installation-Related Problem	3	3
Positioning Failure	2	2
Loose or Intermittent Connection	2	2
Structural Problem	2	2
Difficult or Delayed Positioning	2	2
Device Handling Problem	2	2
Fire	2	2
Off-Label Use	2	2
Power Problem	2	2
Loss of or Failure to Bond	1	1
Sparking	1	1
Device Contaminated at the User Facility	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2241	2255
No Consequences Or Impact To Patient	77	77
Burn(s)	22	22
Insufficient Information	17	17
Full thickness (Third Degree) Burn	10	10
Pain	6	6
Partial thickness (Second Degree) Burn	6	6
Superficial (First Degree) Burn	5	5
Concussion	5	5
Erythema	4	4
Laceration(s)	4	4
Bruise/Contusion	4	4
Head Injury	3	3
Abrasion	3	3
Foreign Body In Patient	3	3
Scar Tissue	3	3
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