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	1106	1117
Peeled/Delaminated	898	902
Corroded	268	268
Crack	162	162
Fluid/Blood Leak	65	65
No Apparent Adverse Event	55	55
Flaked	49	49
Break	46	46
Fracture	42	42
Material Erosion	42	42
Leak/Splash	34	34
Material Split, Cut or Torn	33	33
Mechanical Problem	31	31
Material Integrity Problem	26	26
Degraded	25	25
Insufficient Information	20	20
Material Separation	20	20
Unintended Movement	14	14
Use of Device Problem	13	13
Device Fell	11	11
Moisture Damage	10	10
Electrical /Electronic Property Problem	9	9
Grounding Malfunction	8	9
Material Fragmentation	6	6
Failure to Clean Adequately	5	5
Unexpected Shutdown	5	5
Scratched Material	5	5
Overheating of Device	4	4
Device Dislodged or Dislocated	4	4
Excessive Heating	4	4
Appropriate Term/Code Not Available	4	4
Pitted	3	3
Unintended Collision	3	3
Installation-Related Problem	3	3
Defective Component	3	3
Naturally Worn	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Temperature Problem	3	3
Positioning Failure	2	2
Difficult or Delayed Positioning	2	2
Fire	2	2
Off-Label Use	2	2
Structural Problem	2	2
Power Problem	2	2
Loose or Intermittent Connection	2	2
Device Handling Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Smoking	1	1
Device Damaged Prior to Use	1	1
Device Contaminated at the User Facility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2164	2178
No Consequences Or Impact To Patient	77	77
Burn(s)	21	21
Insufficient Information	16	16
Full thickness (Third Degree) Burn	10	10
Partial thickness (Second Degree) Burn	5	5
Superficial (First Degree) Burn	4	4
Laceration(s)	4	4
Bruise/Contusion	4	4
Abrasion	3	3
Foreign Body In Patient	3	3
Concussion	3	3
Erythema	3	3
Pain	3	3
Scar Tissue	3	3
Eye Injury	2	2
Skin Tears	2	2
Headache	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hematoma	1	1
Head Injury	1	1
Burn, Thermal	1	1
No Known Impact Or Consequence To Patient	1	1
Skin Discoloration	1	1
Burning Sensation	1	1
No Patient Involvement	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1