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	4619	4620
Excessive Heating	858	859
Detachment of Device or Device Component	754	754
Device Remains Activated	557	557
Vibration	513	515
Noise, Audible	380	380
Device Damaged by Another Device	328	328
Break	312	313
Complete Loss of Power	264	264
Fluid/Blood Leak	222	222
Fail-Safe Did Not Operate	206	206
Appropriate Device Problem Term/Code Not Available	175	175
Unintended System Motion	164	164
Leak/Splash	157	157
Fracture	155	155
Mechanical Jam	155	155
Output below Specifications	131	131
Flaked	117	117
Unintended Power Up	117	117
Device-Device Incompatibility	108	109
Material Fragmentation	106	106
Fail-Safe Problem	54	54
Mechanical Problem	54	54
No Apparent Adverse Event	50	50
Difficult or Delayed Separation	44	44
Use of Device Problem	41	41
Power Problem	36	36
Self-Activation or Keying	33	33
Premature Separation	31	31
Output Problem	31	31
Material Disintegration	30	30
Difficult to Insert	28	28
Physical Resistance/Sticking	27	27
Intermittent Loss of Power	26	26
Connection Problem	25	25
Naturally Worn	24	24
Component Missing	20	20
Environmental Particulates	18	18
Device Alarm System	17	17
Incorrect Interpretation of Signal	17	17
Separation Problem	17	17
Unintended Movement	15	15
Device Slipped	15	15
Unexpected Shutdown	15	15
Loss of Power	15	15
Defective Component	13	13
Material Twisted/Bent	12	12
Display or Visual Feedback Problem	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Energy Output Problem	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9155	9158
Insufficient Information	222	222
Burn(s)	51	51
Superficial (First Degree) Burn	12	12
Unspecified Tissue Injury	9	9
Hemorrhage/Blood Loss/Bleeding	7	7
Foreign Body In Patient	5	6
Partial thickness (Second Degree) Burn	4	4
Unspecified Infection	3	3
Intracranial Hemorrhage	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Numbness	2	2
Nerve Damage	2	2
Intraoperative Cardiac Valve Injury	2	2
No Patient Involvement	1	1
Hypersensitivity/Allergic reaction	1	1
Arrhythmia	1	1
Perforation	1	1
Hearing Impairment	1	1
Sinus Perforation	1	1
Abrasion	1	1
Pain	1	1
Eye Injury	1	1
Cerebrospinal Fluid Leakage	1	1
Visual Impairment	1	1
Dizziness	1	1
Fatigue	1	1
Shock	1	1
Laceration(s)	1	1
Full thickness (Third Degree) Burn	1	1

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