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	879	879
Fracture	125	125
Break	98	98
Complete Loss of Power	79	79
Mechanical Problem	72	72
Appropriate Term/Code Not Available	58	58
Difficult to Open or Close	50	50
Unintended System Motion	31	31
Leak/Splash	29	29
Fire	17	17
Overheating of Device	17	17
Fluid/Blood Leak	16	16
Crack	16	16
Failure to Charge	15	15
Premature Separation	15	15
Structural Problem	15	15
Fail-Safe Did Not Operate	14	14
Electrical /Electronic Property Problem	12	12
Material Deformation	7	7
Material Integrity Problem	7	7
Noise, Audible	6	6
Detachment of Device or Device Component	6	6
Use of Device Problem	6	6
Excessive Heating	5	5
Device-Device Incompatibility	5	5
Difficult to Remove	4	4
Difficult to Insert	4	4
Mechanical Jam	4	4
Fail-Safe Problem	3	3
Vibration	3	3
Smoking	3	3
Device Fell	3	3
Unintended Electrical Shock	3	3
Premature Discharge of Battery	3	3
Output below Specifications	3	3
Positioning Problem	2	2
Difficult or Delayed Separation	2	2
Insufficient Information	2	2
Environmental Particulates	2	2
No Apparent Adverse Event	2	2
Explosion	2	2
Failure to Conduct	2	2
Power Problem	2	2
Connection Problem	2	2
Device Alarm System	2	2
Physical Resistance/Sticking	2	2
Improper or Incorrect Procedure or Method	2	2
Circuit Failure	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Electrical Overstress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1333	1333
Insufficient Information	169	169
No Information	2	2
Superficial (First Degree) Burn	1	1
Electric Shock	1	1
Bone Fracture(s)	1	1
Unspecified Tissue Injury	1	1
Sore Throat	1	1

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