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	1201	1201
Unstable	434	434
Patient Device Interaction Problem	377	377
Power Problem	368	368
Appropriate Term/Code Not Available	292	292
Intermittent Loss of Power	242	242
Gas/Air Leak	227	227
Calibration Problem	157	157
Material Frayed	142	142
Noise, Audible	130	130
Material Deformation	112	112
Mechanical Problem	110	110
Failure to Power Up	109	109
Component Missing	100	100
Naturally Worn	99	99
Incorrect, Inadequate or Imprecise Result or Readings	78	78
Corroded	75	75
Loose or Intermittent Connection	73	73
Physical Resistance/Sticking	70	70
Insufficient Information	68	68
Break	64	64
Fitting Problem	58	58
Output Problem	52	52
Output below Specifications	52	52
Electrical /Electronic Property Problem	42	42
Material Integrity Problem	32	32
Adverse Event Without Identified Device or Use Problem	30	30
Incorrect Measurement	28	28
Positioning Problem	25	25
Detachment of Device or Device Component	24	24
Material Twisted/Bent	22	22
Structural Problem	22	22
Activation Problem	21	21
Loss of Power	19	19
Vibration	19	19
Pressure Problem	18	18
Unexpected Shutdown	18	18
Dull, Blunt	15	15
Material Split, Cut or Torn	15	15
Failure to Disconnect	14	14
Overheating of Device	13	13
Connection Problem	12	12
Key or Button Unresponsive/not Working	10	10
Complete Loss of Power	9	9
Electrical Power Problem	9	9
Fluid/Blood Leak	7	7
Mechanical Jam	7	7
Degraded	7	7
Use of Device Problem	7	7
Misassembled	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2558	2558
Laceration(s)	310	310
No Consequences Or Impact To Patient	174	174
No Patient Involvement	170	170
Insufficient Information	165	165
Abrasion	131	131
No Known Impact Or Consequence To Patient	90	90
Unspecified Tissue Injury	62	62
Skin Tears	54	54
Scar Tissue	15	15
Injury	10	10
Impaired Healing	9	9
Localized Skin Lesion	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
No Code Available	6	6
Physical Asymmetry	6	6
Muscle/Tendon Damage	4	4
Patient Problem/Medical Problem	2	2
Failure of Implant	2	2
No Information	2	2
Burn(s)	2	2
Superficial (First Degree) Burn	1	1
Adhesion(s)	1	1
Crushing Injury	1	1
Scarring	1	1
Suture Abrasion	1	1
Hair Loss	1	1
Partial Hearing Loss	1	1
Wrinkling	1	1
Tissue Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Headache	1	1
Tissue Breakdown	1	1
Full thickness (Third Degree) Burn	1	1