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	1323	1325
Unstable	479	479
Patient Device Interaction Problem	382	383
Power Problem	369	369
Appropriate Term/Code Not Available	314	314
Gas/Air Leak	248	248
Intermittent Loss of Power	244	244
Calibration Problem	166	166
Noise, Audible	154	154
Mechanical Problem	146	146
Material Frayed	145	145
Material Deformation	135	135
Naturally Worn	124	124
Failure to Power Up	117	117
Component Missing	111	111
Corroded	91	91
Loose or Intermittent Connection	84	84
Output below Specifications	83	83
Insufficient Information	81	81
Incorrect, Inadequate or Imprecise Result or Readings	78	78
Physical Resistance/Sticking	78	78
Break	75	75
Fitting Problem	66	66
Output Problem	52	52
Electrical /Electronic Property Problem	44	44
Incorrect Measurement	40	40
Material Integrity Problem	35	35
Adverse Event Without Identified Device or Use Problem	30	30
Detachment of Device or Device Component	26	26
Unexpected Shutdown	26	26
Positioning Problem	26	26
Activation Problem	25	25
Material Twisted/Bent	24	24
Structural Problem	22	22
Vibration	22	22
Loss of Power	19	19
Material Split, Cut or Torn	18	18
Pressure Problem	18	18
Dull, Blunt	15	15
Key or Button Unresponsive/not Working	15	15
Overheating of Device	15	15
Failure to Disconnect	14	14
Complete Loss of Power	13	13
Connection Problem	13	13
Electrical Power Problem	9	9
Mechanical Jam	8	8
Use of Device Problem	8	8
Fluid/Blood Leak	7	7
Degraded	7	7
Misassembled	7	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2792	2793
Laceration(s)	351	352
Insufficient Information	268	268
No Consequences Or Impact To Patient	174	174
No Patient Involvement	170	170
Abrasion	140	140
No Known Impact Or Consequence To Patient	90	90
Unspecified Tissue Injury	65	65
Skin Tears	63	63
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