TPLC - Total Product Life Cycle

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Device	drill, surgical, ent (electric or pneumatic) including handpiece
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	5225	5225
Excessive Heating	772	772
Device Remains Activated	653	653
Detachment of Device or Device Component	580	580
Vibration	379	379
Noise, Audible	369	369
Break	295	295
Output below Specifications	271	271
Device Damaged by Another Device	260	260
Fluid/Blood Leak	245	245
Fail-Safe Did Not Operate	233	233
Complete Loss of Power	199	199
Leak/Splash	189	189
Unintended Power Up	150	150
Fracture	143	143
Appropriate Term/Code Not Available	133	133
Mechanical Jam	130	130
Flaked	123	123
Unintended System Motion	110	110
Device-Device Incompatibility	94	94
Material Fragmentation	90	90
Mechanical Problem	55	55
Fail-Safe Problem	54	54
Use of Device Problem	42	42
Difficult or Delayed Separation	34	34
Material Twisted/Bent	32	32
Material Disintegration	28	28
Self-Activation or Keying	27	27
Premature Separation	25	25
Unintended Movement	22	22
Connection Problem	21	21
Component Missing	21	21
Intermittent Loss of Power	20	20
Physical Resistance/Sticking	17	17
Separation Problem	16	16
Energy Output Problem	14	14
Smoking	14	14
Device Alarm System	13	13
Device Slipped	13	13
Incorrect Interpretation of Signal	12	12
Environmental Particulates	11	11
Defective Device	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Power Problem	9	9
Display or Visual Feedback Problem	9	9
Output Problem	9	9
Device Reprocessing Problem	8	8
Material Separation	7	7
Unintended Ejection	7	7
Material Frayed	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8179	8179
No Patient Involvement	943	943
No Consequences Or Impact To Patient	701	701
Insufficient Information	121	121
No Known Impact Or Consequence To Patient	51	51
Burn(s)	41	41
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
Bone Fracture(s)	2	2
Numbness	2	2
Eye Injury	2	2
Shock	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Arrhythmia	1	1
Hypersensitivity/Allergic reaction	1	1
Radiation Exposure, Unintended	1	1
Fatigue	1	1
Dizziness	1	1
Sinus Perforation	1	1
Perforation	1	1
Abrasion	1	1
Oversedation	1	1
Intracranial Hemorrhage	1	1
Nerve Damage	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