TPLC - Total Product Life Cycle

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Device	dermatome
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	GFD
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	1247	1249
Unstable	473	473
Patient Device Interaction Problem	372	373
Appropriate Term/Code Not Available	341	341
Power Problem	292	292
Gas/Air Leak	240	240
Intermittent Loss of Power	206	206
Calibration Problem	171	171
Mechanical Problem	159	159
Noise, Audible	158	158
Material Deformation	142	142
Naturally Worn	138	138
Failure to Power Up	124	124
Material Frayed	115	115
Component Missing	102	102
Insufficient Information	96	96
Corroded	96	96
Output below Specifications	91	91
Loose or Intermittent Connection	88	88
Physical Resistance/Sticking	81	81
Break	73	73
Fitting Problem	65	65
Incorrect Measurement	62	62
Incorrect, Inadequate or Imprecise Result or Readings	56	56
Electrical /Electronic Property Problem	44	44
Unexpected Shutdown	37	37
Material Integrity Problem	35	35
Detachment of Device or Device Component	30	30
Output Problem	30	30
Material Twisted/Bent	28	28
Activation Problem	27	27
Adverse Event Without Identified Device or Use Problem	24	24
Positioning Problem	22	22
Structural Problem	21	21
Vibration	19	19
Pressure Problem	18	18
Key or Button Unresponsive/not Working	18	18
Overheating of Device	15	15
Material Split, Cut or Torn	15	15
Dull, Blunt	15	15
Loss of Power	14	14
Failure to Disconnect	14	14
Complete Loss of Power	14	14
Connection Problem	12	12
Electrical Power Problem	9	9
Mechanical Jam	7	7
Intermittent Energy Output	7	7
Fluid/Blood Leak	7	7
Delivered as Unsterile Product	7	7
Misassembled	6	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2980	2981
Insufficient Information	348	348
Laceration(s)	337	338
Abrasion	114	114
Unspecified Tissue Injury	67	67
Skin Tears	61	61
No Consequences Or Impact To Patient	25	25
No Patient Involvement	15	15
Scar Tissue	14	14
Impaired Healing	10	10
No Known Impact Or Consequence To Patient	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Localized Skin Lesion	6	6
Physical Asymmetry	6	6
Muscle/Tendon Damage	4	4
Failure of Implant	2	2
Superficial (First Degree) Burn	1	1
Crushing Injury	1	1
Burn(s)	1	1
Hair Loss	1	1
Partial Hearing Loss	1	1
Wrinkling	1	1
Partial thickness (Second Degree) Burn	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1
Full thickness (Third Degree) Burn	1	1