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	3848	3854
Complete Loss of Power	3025	3025
Mechanical Jam	2608	2608
Excessive Heating	1495	1495
Fracture	1378	2010
Break	1370	1376
Output below Specifications	989	989
Appropriate Term/Code Not Available	943	943
Detachment of Device or Device Component	903	1641
Noise, Audible	773	773
Failure to Cut	648	648
Unintended System Motion	613	614
Intermittent Loss of Power	559	559
Device-Device Incompatibility	452	452
Overheating of Device	289	431
Fluid/Blood Leak	240	743
Device Remains Activated	213	675
Mechanical Problem	210	211
Material Fragmentation	177	261
Naturally Worn	177	177
Material Disintegration	162	454
Leak/Splash	160	160
Device Slipped	160	160
Material Twisted/Bent	152	152
Vibration	142	142
Premature Separation	131	131
Fail-Safe Did Not Operate	120	346
Material Deformation	112	112
Flaked	109	1360
Entrapment of Device	100	100
Fail-Safe Problem	87	191
Electrical /Electronic Property Problem	79	79
Corroded	79	79
Defective Device	70	70
Adverse Event Without Identified Device or Use Problem	63	63
Difficult to Open or Close	54	206
Energy Output Problem	45	45
Crack	45	45
Unintended Movement	44	45
Material Integrity Problem	41	41
Compatibility Problem	37	37
Dull, Blunt	35	35
Unintended Power Up	31	37
Material Separation	30	30
Environmental Particulates	30	30
Material Split, Cut or Torn	29	29
Contamination /Decontamination Problem	28	28
Smoking	27	27
Component Missing	25	25
Device Reprocessing Problem	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13897	18196
No Consequences Or Impact To Patient	2274	2605
Insufficient Information	589	759
Foreign Body In Patient	342	343
No Patient Involvement	236	799
No Known Impact Or Consequence To Patient	153	254
Device Embedded In Tissue or Plaque	98	98
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	17	17
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
Tissue Damage	2	2
Hemorrhage/Bleeding	2	2
Skin Discoloration	1	2
Rupture	1	1
Nerve Damage	1	1
Limb Fracture	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