TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	2821	2821
Complete Loss of Power	2049	2049
Excessive Heating	884	885
Appropriate Term/Code Not Available	597	597
Mechanical Jam	549	549
Unintended System Motion	461	461
Intermittent Loss of Power	400	400
Detachment of Device or Device Component	378	379
Material Fragmentation	329	329
Device Alarm System	317	317
Noise, Audible	312	312
Device-Device Incompatibility	240	240
Output below Specifications	232	232
Vibration	222	222
Break	215	215
Leak/Splash	170	170
Fail-Safe Did Not Operate	144	144
Device Slipped	115	115
Material Frayed	107	107
Premature Separation	79	79
Fail-Safe Problem	75	75
Fracture	62	62
Mechanical Problem	48	48
Device Reprocessing Problem	45	45
Difficult or Delayed Separation	44	44
Intermittent Energy Output	41	41
Overheating of Device	38	38
Circuit Failure	34	34
Component Missing	22	22
Electrical /Electronic Property Problem	22	22
Environmental Particulates	20	20
Fluid/Blood Leak	18	18
Packaging Problem	18	18
Device Contaminated During Manufacture or Shipping	15	15
Energy Output Problem	13	13
Corroded	13	13
Separation Failure	12	12
Improper or Incorrect Procedure or Method	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Suction Failure	9	9
Separation Problem	9	10
Unintended Movement	8	8
Loosening of Implant Not Related to Bone-Ingrowth	7	14
Fire	7	7
Connection Problem	7	7
Device Markings/Labelling Problem	6	6
Contamination /Decontamination Problem	4	4
Positioning Failure	4	4
Decrease in Suction	4	4
Difficult to Open or Close	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6726	6727
Osteolysis	7	14
Unspecified Tissue Injury	7	7
Insufficient Information	6	6
Embolism/Embolus	4	4
Burn(s)	4	5
Limb Fracture	4	4
Unspecified Infection	2	2
Perforation	2	2
Superficial (First Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bone Fracture(s)	1	1
Post Operative Wound Infection	1	1
Foreign Body In Patient	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Partial thickness (Second Degree) Burn	1	1
Headache	1	1
Tinnitus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Pro-Dex Inc	II	Jul-05-2023