TPLC - Total Product Life Cycle

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Device	battery, replacement, rechargeable
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	MOQ
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Battery Problem	937	937
Complete Loss of Power	95	95
Fracture	92	92
Mechanical Problem	65	65
Break	62	62
Appropriate Term/Code Not Available	58	58
Unintended System Motion	36	36
Failure to Charge	26	26
Leak/Splash	23	23
Difficult to Open or Close	22	22
Fire	21	21
Overheating of Device	18	18
Premature Separation	17	17
Fail-Safe Did Not Operate	17	17
Crack	14	14
Fluid/Blood Leak	13	13
Structural Problem	11	11
Electrical /Electronic Property Problem	7	7
Detachment of Device or Device Component	6	6
Charging Problem	6	6
Use of Device Problem	6	6
Excessive Heating	5	5
Material Integrity Problem	5	5
Device-Device Incompatibility	5	5
Difficult to Remove	4	4
Mechanical Jam	4	4
Noise, Audible	4	4
Fail-Safe Problem	3	3
Vibration	3	3
Device Fell	3	3
Melted	3	3
Physical Resistance/Sticking	3	3
Premature Discharge of Battery	3	3
Output below Specifications	3	3
Smoking	2	2
Difficult or Delayed Separation	2	2
No Apparent Adverse Event	2	2
Explosion	2	2
Insufficient Information	2	2
Power Problem	2	2
Device Alarm System	2	2
Positioning Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Power Up	1	1
Component Missing	1	1
Material Separation	1	1
Environmental Particulates	1	1
Unintended Movement	1	1
Separation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1234	1234
Insufficient Information	168	168
No Consequences Or Impact To Patient	55	55
No Patient Involvement	31	31
No Information	6	6
No Known Impact Or Consequence To Patient	2	2
Superficial (First Degree) Burn	1	1
Bone Fracture(s)	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Pro-Dex Inc	II	Oct-31-2024