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	2673	2673
Complete Loss of Power	1752	1752
Excessive Heating	954	954
Appropriate Term/Code Not Available	548	548
Unintended System Motion	525	525
Mechanical Jam	493	493
Detachment of Device or Device Component	387	387
Intermittent Loss of Power	360	360
Noise, Audible	353	353
Device Alarm System	345	345
Material Fragmentation	326	326
Device-Device Incompatibility	231	231
Vibration	224	224
Output below Specifications	219	219
Break	207	207
Leak/Splash	169	169
Fail-Safe Did Not Operate	152	152
Device Slipped	113	113
Material Frayed	107	107
Fail-Safe Problem	75	75
Premature Separation	63	63
Fracture	61	61
Mechanical Problem	45	45
Difficult or Delayed Separation	41	41
Device Reprocessing Problem	39	39
Overheating of Device	36	36
Intermittent Energy Output	30	30
Electrical /Electronic Property Problem	21	21
Component Missing	21	21
Adverse Event Without Identified Device or Use Problem	20	20
Environmental Particulates	19	19
Packaging Problem	18	18
Circuit Failure	16	16
Energy Output Problem	13	13
Fluid/Blood Leak	12	12
Separation Failure	12	12
Corroded	11	11
Device Contaminated During Manufacture or Shipping	9	9
Unintended Movement	8	8
Improper or Incorrect Procedure or Method	8	8
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Separation Problem	7	7
Fire	6	6
Suction Failure	6	6
Connection Problem	6	6
Positioning Failure	4	4
Difficult to Open or Close	4	4
Contamination /Decontamination Problem	4	4
Failure to Cut	3	3
Device Markings/Labelling Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5912	5912
No Consequences Or Impact To Patient	799	799
No Known Impact Or Consequence To Patient	23	23
Osteolysis	7	7
Unspecified Tissue Injury	7	7
Bone Fracture(s)	6	6
Insufficient Information	6	6
Injury	5	5
Burn(s)	5	5
Embolism/Embolus	4	4
Limb Fracture	4	4
Foreign Body In Patient	3	3
Unspecified Infection	2	2
Post Operative Wound Infection	1	1
Headache	1	1
Blood Loss	1	1
Superficial (First Degree) Burn	1	1
Partial thickness (Second Degree) Burn	1	1
Not Applicable	1	1
No Code Available	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Laceration(s)	1	1
Nerve Damage	1	1
Tinnitus	1	1
Unspecified Musculoskeletal problem	1	1

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