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	1132	1132
Unstable	419	419
Power Problem	366	366
Patient Device Interaction Problem	363	363
Appropriate Term/Code Not Available	268	268
Intermittent Loss of Power	235	235
Gas/Air Leak	212	212
Calibration Problem	147	147
Material Frayed	141	141
Noise, Audible	117	117
Material Deformation	105	105
Mechanical Problem	104	104
Failure to Power Up	99	99
Component Missing	95	95
Naturally Worn	86	86
Incorrect, Inadequate or Imprecise Result or Readings	78	78
Corroded	68	68
Loose or Intermittent Connection	65	65
Insufficient Information	63	63
Physical Resistance/Sticking	61	61
Break	59	59
Fitting Problem	55	55
Output Problem	51	51
Electrical /Electronic Property Problem	42	42
Output below Specifications	37	37
Adverse Event Without Identified Device or Use Problem	30	30
Incorrect Measurement	27	27
Material Integrity Problem	27	27
Positioning Problem	25	25
Structural Problem	22	22
Material Twisted/Bent	22	22
Detachment of Device or Device Component	21	21
Loss of Power	19	19
Vibration	19	19
Activation Problem	19	19
Pressure Problem	16	16
Dull, Blunt	15	15
Unexpected Shutdown	15	15
Material Split, Cut or Torn	14	14
Failure to Disconnect	13	13
Overheating of Device	12	12
Connection Problem	12	12
Electrical Power Problem	9	9
Key or Button Unresponsive/not Working	8	8
Fluid/Blood Leak	7	7
Complete Loss of Power	7	7
Degraded	7	7
Mechanical Jam	6	6
Misassembled	6	6
Improper or Incorrect Procedure or Method	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2439	2439
Laceration(s)	294	294
No Consequences Or Impact To Patient	174	174
No Patient Involvement	170	170
Abrasion	131	131
Insufficient Information	98	98
No Known Impact Or Consequence To Patient	90	90
Unspecified Tissue Injury	59	59
Skin Tears	28	28
Scar Tissue	15	15
Injury	10	10
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
Impaired Healing	5	5
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