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	2890	2890
Complete Loss of Power	1911	1911
Excessive Heating	975	975
Appropriate Term/Code Not Available	572	572
Unintended System Motion	535	535
Mechanical Jam	525	525
Detachment of Device or Device Component	411	411
Intermittent Loss of Power	383	383
Noise, Audible	368	368
Material Fragmentation	365	365
Device Alarm System	345	345
Device-Device Incompatibility	242	242
Output below Specifications	229	229
Vibration	226	226
Break	215	215
Leak/Splash	181	181
Fail-Safe Did Not Operate	153	153
Device Slipped	115	115
Material Frayed	107	107
Fail-Safe Problem	75	75
Premature Separation	70	70
Fracture	63	63
Mechanical Problem	47	47
Difficult or Delayed Separation	44	44
Device Reprocessing Problem	41	41
Overheating of Device	37	37
Intermittent Energy Output	37	37
Electrical /Electronic Property Problem	23	23
Component Missing	21	21
Environmental Particulates	20	20
Adverse Event Without Identified Device or Use Problem	20	20
Circuit Failure	18	18
Packaging Problem	18	18
Fluid/Blood Leak	14	14
Corroded	13	13
Energy Output Problem	13	13
Separation Failure	12	12
Improper or Incorrect Procedure or Method	10	10
Device Contaminated During Manufacture or Shipping	9	9
Separation Problem	8	8
Unintended Movement	8	8
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Fire	7	7
Connection Problem	7	7
Suction Failure	5	5
Positioning Failure	4	4
Difficult to Open or Close	4	4
Contamination /Decontamination Problem	4	4
Compatibility Problem	3	3
Premature Discharge of Battery	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6320	6320
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
Burn(s)	5	5
Injury	5	5
Insufficient Information	5	5
Embolism/Embolus	4	4
Limb Fracture	4	4
Foreign Body In Patient	3	3
Unspecified Infection	2	2
Perforation	2	2
Superficial (First Degree) Burn	1	1
Not Applicable	1	1
No Code Available	1	1
Unspecified Musculoskeletal problem	1	1
Blood Loss	1	1
Post Operative Wound Infection	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