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

Premarket Reviews
Manufacturer	Decision
BIEN-AIR SURGERY SA
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
W&H DENTALWERK BUERMOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZETHON LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	5337	5337
Excessive Heating	825	825
Device Remains Activated	662	662
Detachment of Device or Device Component	629	629
Vibration	486	486
Noise, Audible	391	391
Break	309	309
Device Damaged by Another Device	279	279
Output below Specifications	271	271
Fluid/Blood Leak	248	248
Fail-Safe Did Not Operate	239	239
Complete Loss of Power	217	217
Leak/Splash	196	196
Unintended Power Up	156	156
Fracture	150	150
Appropriate Term/Code Not Available	149	149
Mechanical Jam	138	138
Flaked	128	128
Unintended System Motion	126	126
Material Fragmentation	106	106
Device-Device Incompatibility	100	100
Mechanical Problem	56	56
Fail-Safe Problem	54	54
Use of Device Problem	42	42
Difficult or Delayed Separation	38	38
Material Twisted/Bent	33	33
Material Disintegration	28	28
Self-Activation or Keying	28	28
Premature Separation	25	25
Unintended Movement	22	22
Connection Problem	22	22
Component Missing	21	21
Intermittent Loss of Power	21	21
Physical Resistance/Sticking	19	19
Separation Problem	16	16
Incorrect Interpretation of Signal	16	16
Device Alarm System	15	15
Energy Output Problem	14	14
Smoking	14	14
Device Slipped	14	14
Environmental Particulates	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Defective Device	11	11
Output Problem	11	11
Display or Visual Feedback Problem	10	10
Power Problem	9	9
Device Reprocessing Problem	8	8
Material Frayed	8	8
Corroded	7	7
Unintended Ejection	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8594	8594
No Patient Involvement	943	943
No Consequences Or Impact To Patient	701	701
Insufficient Information	128	128
No Known Impact Or Consequence To Patient	51	51
Burn(s)	43	43
Superficial (First Degree) Burn	11	11
Partial thickness (Second Degree) Burn	9	9
Unspecified Tissue Injury	8	8
No Information	7	7
Hemorrhage/Bleeding	7	7
Foreign Body In Patient	5	5
Unspecified Infection	3	3
Burn, Thermal	3	3
Hearing Impairment	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bone Fracture(s)	2	2
Nerve Damage	2	2
Numbness	2	2
Eye Injury	2	2
Shock	2	2
Arrhythmia	1	1
Hypersensitivity/Allergic reaction	1	1
Fatigue	1	1
Radiation Exposure, Unintended	1	1
Dizziness	1	1
Perforation	1	1
Sinus Perforation	1	1
Abrasion	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Laceration(s)	1	1
Pain	1	1
Visual Impairment	1	1
Cerebrospinal Fluid Leakage	1	1
Full thickness (Third Degree) Burn	1	1