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	1219	1219
Unstable	434	434
Patient Device Interaction Problem	377	377
Power Problem	369	369
Appropriate Term/Code Not Available	298	298
Intermittent Loss of Power	242	242
Gas/Air Leak	230	230
Calibration Problem	160	160
Material Frayed	143	143
Noise, Audible	131	131
Material Deformation	113	113
Mechanical Problem	113	113
Failure to Power Up	111	111
Naturally Worn	102	102
Component Missing	101	101
Corroded	79	79
Incorrect, Inadequate or Imprecise Result or Readings	78	78
Loose or Intermittent Connection	73	73
Physical Resistance/Sticking	71	71
Insufficient Information	68	68
Break	65	65
Output below Specifications	60	60
Fitting Problem	60	60
Output Problem	52	52
Electrical /Electronic Property Problem	42	42
Material Integrity Problem	33	33
Incorrect Measurement	30	30
Adverse Event Without Identified Device or Use Problem	30	30
Positioning Problem	25	25
Detachment of Device or Device Component	24	24
Material Twisted/Bent	24	24
Activation Problem	22	22
Structural Problem	22	22
Unexpected Shutdown	20	20
Vibration	19	19
Loss of Power	19	19
Pressure Problem	18	18
Material Split, Cut or Torn	15	15
Dull, Blunt	15	15
Overheating of Device	15	15
Failure to Disconnect	14	14
Connection Problem	12	12
Key or Button Unresponsive/not Working	10	10
Complete Loss of Power	10	10
Electrical Power Problem	9	9
Mechanical Jam	7	7
Degraded	7	7
Use of Device Problem	7	7
Fluid/Blood Leak	7	7
Misassembled	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2597	2597
Laceration(s)	314	314
Insufficient Information	191	191
No Consequences Or Impact To Patient	174	174
No Patient Involvement	170	170
Abrasion	131	131
No Known Impact Or Consequence To Patient	90	90
Unspecified Tissue Injury	63	63
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
Scarring	1	1
Suture Abrasion	1	1
Crushing Injury	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
Full thickness (Third Degree) Burn	1	1
Tissue Breakdown	1	1