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	3963	3970
Complete Loss of Power	3419	3419
Mechanical Jam	3049	3049
Break	1523	1532
Excessive Heating	1428	1428
Fracture	1176	1711
Appropriate Term/Code Not Available	1176	1177
Detachment of Device or Device Component	919	1568
Noise, Audible	699	699
Failure to Cut	649	651
Intermittent Loss of Power	554	554
Output below Specifications	515	515
Device-Device Incompatibility	489	489
Unintended System Motion	478	479
Mechanical Problem	313	313
Overheating of Device	290	397
Fluid/Blood Leak	226	677
Device Slipped	216	217
Material Fragmentation	200	285
Device Remains Activated	193	499
Leak/Splash	179	179
Naturally Worn	177	178
Material Disintegration	175	475
Material Twisted/Bent	171	171
Premature Separation	157	157
Material Deformation	146	146
Fail-Safe Did Not Operate	119	390
Flaked	115	1854
Electrical /Electronic Property Problem	112	112
Entrapment of Device	107	111
Vibration	106	106
Corroded	80	81
Defective Device	65	65
Adverse Event Without Identified Device or Use Problem	58	58
Fail-Safe Problem	56	88
Difficult to Open or Close	55	163
Material Integrity Problem	44	46
Unintended Movement	43	44
Power Problem	42	42
Compatibility Problem	41	41
Crack	36	37
Material Split, Cut or Torn	34	34
Positioning Failure	33	33
Unintended Power Up	32	36
Component Missing	32	32
Device Reprocessing Problem	31	31
Environmental Particulates	29	29
Use of Device Problem	29	29
Difficult or Delayed Separation	28	29
Smoking	28	28

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16039	20650
Insufficient Information	637	808
Foreign Body In Patient	357	362
Device Embedded In Tissue or Plaque	85	92
Burn(s)	29	29
Skin Tears	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Unspecified Tissue Injury	18	19
Bone Fracture(s)	9	9
Superficial (First Degree) Burn	8	8
Perforation	6	6
Pain	6	6
Unspecified Infection	5	5
Failure of Implant	5	5
Cardiac Perforation	4	4
Abrasion	3	3
Laceration(s)	3	3
Infiltration into Tissue	3	3
Brain Injury	2	2
No Known Impact Or Consequence To Patient	2	2
Limb Fracture	2	2
Swelling/ Edema	2	2
Hemorrhage/Bleeding	2	2
Full thickness (Third Degree) Burn	2	2
Hearing Impairment	1	1
Hypersensitivity/Allergic reaction	1	1
Rupture	1	1
Nerve Damage	1	1
Shock	1	1
Non-union Bone Fracture	1	1
Tinnitus	1	1
No Consequences Or Impact To Patient	1	1