TPLC - Total Product Life Cycle

show TPLC since

Device	handpiece, rotary bone cutting
Product Code	KMW
Regulation Number	872.4120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	133	133
Nonstandard Device	22	22
Temperature Problem	19	19
Power Problem	11	11
Detachment of Device or Device Component	5	5
Use of Device Problem	3	3
Break	2	2
Unintended Power Up	2	2
Failure to Deliver Energy	1	1
Mechanical Problem	1	1
Vibration	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Power Up	1	1
Material Too Rigid or Stiff	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Insufficient Information	1	1
Noise, Audible	1	1
Intermittent Loss of Power	1	1
Unintended Electrical Shock	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	89	89
Partial thickness (Second Degree) Burn	40	40
Superficial (First Degree) Burn	26	26
No Clinical Signs, Symptoms or Conditions	14	14
Insufficient Information	11	11
Burn, Thermal	11	11
Injury	9	9
Patient Problem/Medical Problem	8	8
Full thickness (Third Degree) Burn	3	3
Erythema	2	2
Swelling	2	2
Burning Sensation	1	1
No Consequences Or Impact To Patient	1	1
Scarring	1	1
Numbness	1	1
Electric Shock	1	1
Blister	1	1
Unspecified Tissue Injury	1	1
No Known Impact Or Consequence To Patient	1	1
Abrasion	1	1