TPLC - Total Product Life Cycle

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Device	motor, surgical instrument, ac-powered
Product Code	GEY
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	2319	2319
Complete Loss of Power	1489	1489
Excessive Heating	906	906
Mechanical Jam	727	727
Unintended System Motion	552	552
Detachment of Device or Device Component	462	462
Appropriate Term/Code Not Available	440	440
Noise, Audible	407	407
Intermittent Loss of Power	336	336
Device Alarm System	319	319
Material Fragmentation	297	297
Vibration	214	214
Output below Specifications	208	208
Device-Device Incompatibility	197	197
Break	186	186
Leak/Splash	182	182
Fail-Safe Did Not Operate	139	139
Intermittent Energy Output	113	113
Material Frayed	103	103
Device Slipped	98	98
Unexpected Shutdown	83	83
Overheating of Device	76	76
Fail-Safe Problem	70	70
Fracture	67	67
Fluid/Blood Leak	62	62
Positioning Problem	57	57
Premature Separation	53	53
Mechanical Problem	41	41
Device Reprocessing Problem	37	37
Difficult or Delayed Separation	33	33
Adverse Event Without Identified Device or Use Problem	26	26
Electrical /Electronic Property Problem	21	21
Packaging Problem	17	17
Environmental Particulates	17	17
Loose or Intermittent Connection	16	16
Component Missing	15	15
Circuit Failure	14	14
Separation Failure	12	12
Corroded	11	11
Energy Output Problem	11	11
Material Twisted/Bent	9	9
Device Contaminated During Manufacture or Shipping	9	9
Unintended Movement	8	8
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Difficult to Remove	7	7
Improper or Incorrect Procedure or Method	7	7
Connection Problem	6	6
Crack	6	6
Separation Problem	6	6
Suction Failure	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5052	5052
No Consequences Or Impact To Patient	1586	1586
No Known Impact Or Consequence To Patient	350	350
Bone Fracture(s)	10	10
Osteolysis	7	7
Foreign Body In Patient	6	6
Burn(s)	5	5
Injury	5	5
Insufficient Information	5	5
Unspecified Tissue Injury	5	5
No Code Available	4	4
Embolism/Embolus	4	4
Limb Fracture	4	4
Not Applicable	3	3
Unspecified Infection	2	2
Abrasion	2	2
Tissue Damage	2	2
Superficial (First Degree) Burn	1	1
Tingling	1	1
Electric Shock	1	1
Skin Irritation	1	1
Unspecified Musculoskeletal problem	1	1
Blood Loss	1	1
Post Operative Wound Infection	1	1
Nerve Damage	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Partial thickness (Second Degree) Burn	1	1