TPLC - Total Product Life Cycle

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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	166	166
Temperature Problem	47	47
Nonstandard Device	33	33
Insufficient Information	21	21
Power Problem	9	9
Detachment of Device or Device Component	6	6
Break	5	5
Improper or Incorrect Procedure or Method	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Mechanical Problem	4	4
Use of Device Problem	3	3
Device Operates Differently Than Expected	3	3
Maintenance Does Not Comply To Manufacturers Recommendations	3	3
Unintended Power Up	2	2
Inadequate Instructions for Healthcare Professional	2	2
Device Issue	2	2
Physical Property Issue	2	2
Noise, Audible	2	2
Device Fell	1	1
Intermittent Loss of Power	1	1
Unintended Electrical Shock	1	1
Appropriate Term/Code Not Available	1	1
Output Problem	1	1
Device Maintenance Issue	1	1
Failure to Deliver Energy	1	1
Failure to Power Up	1	1
Material Too Rigid or Stiff	1	1
Failure To Service	1	1
Smoking	1	1
Mechanical Jam	1	1
Vibration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	121	121
Partial thickness (Second Degree) Burn	50	51
Burn, Thermal	46	47
Injury	36	36
Superficial (First Degree) Burn	30	30
Patient Problem/Medical Problem	22	22
No Clinical Signs, Symptoms or Conditions	13	13
Insufficient Information	11	11
Full thickness (Third Degree) Burn	9	9
No Known Impact Or Consequence To Patient	4	4
Peeling	3	3
Scarring	3	3
Swelling	2	2
Erythema	2	2
Unspecified Infection	1	1
Numbness	1	1
Tissue Damage	1	1
Burning Sensation	1	1
No Consequences Or Impact To Patient	1	1
Complaint, Ill-Defined	1	1
Abrasion	1	1
Nervous System Injury	1	1
Foreign Body In Patient	1	1
Electric Shock	1	1
Device Embedded In Tissue or Plaque	1	1
Blister	1	1
Unspecified Tissue Injury	1	1