TPLC - Total Product Life Cycle

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Device	drill, surgical, ent (electric or pneumatic) including handpiece
Regulation Description	Ear, nose, and throat electric or pneumatic surgical drill.
Product Code	ERL
Regulation Number	874.4250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	4385	4386
Excessive Heating	829	830
Detachment of Device or Device Component	644	644
Device Remains Activated	557	557
Vibration	474	476
Noise, Audible	364	364
Device Damaged by Another Device	315	315
Break	314	315
Complete Loss of Power	244	244
Fluid/Blood Leak	222	222
Fail-Safe Did Not Operate	203	203
Appropriate Term/Code Not Available	167	167
Fracture	152	152
Leak/Splash	151	151
Mechanical Jam	150	150
Unintended System Motion	139	139
Output below Specifications	128	128
Unintended Power Up	117	117
Flaked	112	112
Device-Device Incompatibility	105	106
Material Fragmentation	103	103
Mechanical Problem	55	55
Fail-Safe Problem	54	54
Difficult or Delayed Separation	44	44
Use of Device Problem	40	40
Self-Activation or Keying	33	33
Premature Separation	30	30
Material Disintegration	29	29
Connection Problem	25	25
Power Problem	23	23
Intermittent Loss of Power	21	21
Component Missing	20	20
Physical Resistance/Sticking	20	20
Output Problem	18	18
Device Alarm System	17	17
Environmental Particulates	17	17
Separation Problem	17	17
Incorrect Interpretation of Signal	17	17
Unintended Movement	16	16
Unexpected Shutdown	15	15
Device Slipped	15	15
Material Twisted/Bent	12	12
Display or Visual Feedback Problem	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Energy Output Problem	8	8
Temperature Problem	8	8
Material Frayed	8	8
Defective Component	7	7
Smoking	7	7
Insufficient Information	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8565	8568
Insufficient Information	187	187
Burn(s)	46	46
Superficial (First Degree) Burn	12	12
Unspecified Tissue Injury	8	8
Hemorrhage/Bleeding	7	7
Foreign Body In Patient	4	5
Partial thickness (Second Degree) Burn	4	4
Unspecified Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Numbness	2	2
Nerve Damage	2	2
Hearing Impairment	1	1
Arrhythmia	1	1
Hypersensitivity/Allergic reaction	1	1
Fatigue	1	1
Dizziness	1	1
Sinus Perforation	1	1
Perforation	1	1
Abrasion	1	1
Intracranial Hemorrhage	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Pain	1	1
Visual Impairment	1	1
Eye Injury	1	1
Shock	1	1
Cerebrospinal Fluid Leakage	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Xomed, Inc.	II	Apr-20-2022