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	2429	2429
Complete Loss of Power	1613	1613
Excessive Heating	934	934
Unintended System Motion	516	516
Appropriate Term/Code Not Available	495	495
Mechanical Jam	454	454
Detachment of Device or Device Component	360	360
Device Alarm System	345	345
Noise, Audible	343	343
Intermittent Loss of Power	333	333
Material Fragmentation	289	289
Vibration	222	222
Device-Device Incompatibility	214	214
Output below Specifications	212	212
Break	191	191
Leak/Splash	164	164
Fail-Safe Did Not Operate	153	153
Material Frayed	108	108
Device Slipped	106	106
Fail-Safe Problem	74	74
Fracture	60	60
Premature Separation	59	59
Mechanical Problem	43	43
Difficult or Delayed Separation	39	39
Device Reprocessing Problem	36	36
Intermittent Energy Output	28	28
Overheating of Device	28	28
Electrical /Electronic Property Problem	21	21
Adverse Event Without Identified Device or Use Problem	20	20
Component Missing	19	19
Environmental Particulates	18	18
Packaging Problem	18	18
Circuit Failure	15	15
Separation Failure	12	12
Corroded	11	11
Energy Output Problem	11	11
Fluid/Blood Leak	10	10
Device Contaminated During Manufacture or Shipping	9	9
Improper or Incorrect Procedure or Method	8	8
Unintended Movement	8	8
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Separation Problem	6	6
Connection Problem	6	6
Fire	5	5
Suction Failure	5	5
Positioning Failure	4	4
Contamination /Decontamination Problem	4	4
Difficult to Open or Close	4	4
Failure to Cut	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	5497	5497
No Consequences Or Impact To Patient	799	799
No Known Impact Or Consequence To Patient	23	23
Osteolysis	7	7
Bone Fracture(s)	6	6
Unspecified Tissue Injury	6	6
Injury	5	5
Burn(s)	5	5
Insufficient Information	5	5
Embolism/Embolus	4	4
Limb Fracture	4	4
Foreign Body In Patient	3	3
Unspecified Infection	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