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	4456	4463
Complete Loss of Power	3430	3430
Mechanical Jam	2959	2959
Excessive Heating	1603	1603
Break	1603	1618
Fracture	1491	2147
Appropriate Term/Code Not Available	1107	1108
Output below Specifications	1036	1036
Detachment of Device or Device Component	1028	1801
Noise, Audible	857	857
Failure to Cut	675	677
Unintended System Motion	638	639
Intermittent Loss of Power	631	631
Device-Device Incompatibility	526	526
Overheating of Device	312	476
Mechanical Problem	307	308
Fluid/Blood Leak	271	829
Device Remains Activated	233	718
Material Fragmentation	223	310
Device Slipped	201	202
Material Twisted/Bent	196	196
Leak/Splash	193	193
Material Disintegration	192	538
Naturally Worn	180	181
Material Deformation	157	157
Premature Separation	156	156
Vibration	150	150
Fail-Safe Did Not Operate	141	412
Flaked	126	1791
Entrapment of Device	120	124
Electrical /Electronic Property Problem	106	106
Fail-Safe Problem	89	193
Corroded	80	81
Defective Device	71	71
Adverse Event Without Identified Device or Use Problem	66	66
Difficult to Open or Close	61	213
Unintended Movement	47	48
Material Integrity Problem	45	47
Energy Output Problem	45	45
Crack	45	46
Compatibility Problem	44	44
Dull, Blunt	37	37
Unintended Power Up	36	43
Material Separation	31	31
Environmental Particulates	31	31
Component Missing	30	30
Power Problem	30	30
Device Reprocessing Problem	30	30
Material Split, Cut or Torn	30	30
Contamination /Decontamination Problem	30	30

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15955	20941
No Consequences Or Impact To Patient	2274	2605
Insufficient Information	653	850
Foreign Body In Patient	390	395
No Patient Involvement	236	799
No Known Impact Or Consequence To Patient	153	254
Device Embedded In Tissue or Plaque	105	109
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	19	20
No Information	15	28
Bone Fracture(s)	14	14
Superficial (First Degree) Burn	10	10
Pain	6	6
Failure of Implant	6	6
Unspecified Infection	6	6
Perforation	5	5
Burn, Thermal	4	4
Abrasion	4	4
Cardiac Perforation	4	4
Laceration(s)	4	4
Brain Injury	3	3
Infiltration into Tissue	3	3
Full thickness (Third Degree) Burn	3	3
Limb Fracture	2	2
Swelling/ Edema	2	2
Tissue Damage	2	2
Hemorrhage/Bleeding	2	2
Rupture	1	1
Skin Discoloration	1	2
Nerve Damage	1	1
Hypersensitivity/Allergic reaction	1	1
Arrhythmia	1	1
Shock	1	1
Non-union Bone Fracture	1	1
Hearing Impairment	1	1
Patient Problem/Medical Problem	1	1
Tinnitus	1	1