TPLC - Total Product Life Cycle

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Device	instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	HWE
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	4096	4102
Complete Loss of Power	3176	3176
Mechanical Jam	2719	2719
Excessive Heating	1530	1530
Break	1445	1451
Fracture	1416	2057
Output below Specifications	1004	1004
Appropriate Term/Code Not Available	992	992
Detachment of Device or Device Component	941	1692
Noise, Audible	800	800
Failure to Cut	650	650
Unintended System Motion	622	623
Intermittent Loss of Power	585	585
Device-Device Incompatibility	469	469
Overheating of Device	299	452
Mechanical Problem	259	260
Fluid/Blood Leak	252	781
Device Remains Activated	223	692
Material Fragmentation	189	273
Device Slipped	180	180
Naturally Worn	179	179
Material Twisted/Bent	177	177
Leak/Splash	174	174
Material Disintegration	171	488
Vibration	146	146
Premature Separation	137	137
Material Deformation	131	131
Fail-Safe Did Not Operate	126	377
Flaked	115	1506
Entrapment of Device	108	108
Electrical /Electronic Property Problem	89	89
Fail-Safe Problem	87	191
Corroded	80	81
Defective Device	70	70
Adverse Event Without Identified Device or Use Problem	64	64
Difficult to Open or Close	59	211
Crack	45	45
Energy Output Problem	45	45
Unintended Movement	44	45
Material Integrity Problem	42	42
Compatibility Problem	38	38
Dull, Blunt	35	35
Material Separation	31	31
Unintended Power Up	31	37
Environmental Particulates	30	30
Material Split, Cut or Torn	30	30
Component Missing	29	29
Contamination /Decontamination Problem	29	29
Smoking	27	27
Device Reprocessing Problem	27	27

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14644	19199
No Consequences Or Impact To Patient	2274	2605
Insufficient Information	627	807
Foreign Body In Patient	353	354
No Patient Involvement	236	799
No Known Impact Or Consequence To Patient	153	254
Device Embedded In Tissue or Plaque	99	99
No Code Available	66	66
Burn(s)	41	41
Skin Tears	26	26
Injury	26	26
Not Applicable	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Unspecified Tissue Injury	18	18
No Information	15	28
Bone Fracture(s)	14	14
Superficial (First Degree) Burn	10	10
Unspecified Infection	6	6
Failure of Implant	6	6
Pain	5	5
Laceration(s)	4	4
Cardiac Perforation	4	4
Burn, Thermal	4	4
Abrasion	4	4
Brain Injury	3	3
Infiltration into Tissue	3	3
Full thickness (Third Degree) Burn	3	3
Perforation	2	2
Limb Fracture	2	2
Tissue Damage	2	2
Hemorrhage/Bleeding	2	2
Skin Discoloration	1	2
Rupture	1	1
Nerve Damage	1	1
Hypersensitivity/Allergic reaction	1	1
Shock	1	1
Non-union Bone Fracture	1	1
Swelling/ Edema	1	1
Arrhythmia	1	1
Patient Problem/Medical Problem	1	1
Tinnitus	1	1
Hearing Impairment	1	1