TPLC - Total Product Life Cycle

show TPLC since

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
INTERSCOPE, 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	6717	6717
Excessive Heating	736	736
Detachment of Device or Device Component	687	687
Device Remains Activated	675	675
Output below Specifications	428	428
Fluid/Blood Leak	390	390
Noise, Audible	389	389
Vibration	367	367
Break	306	306
Fail-Safe Did Not Operate	240	240
Device Damaged by Another Device	217	217
Unintended System Motion	216	216
Unintended Power Up	215	215
Leak/Splash	202	202
Complete Loss of Power	192	192
Fracture	149	149
Flaked	132	132
Mechanical Jam	128	128
Appropriate Term/Code Not Available	109	109
Material Fragmentation	101	101
Device-Device Incompatibility	92	92
Material Twisted/Bent	91	91
Mechanical Problem	74	74
Fail-Safe Problem	60	60
Use of Device Problem	50	50
Unintended Movement	31	31
Difficult or Delayed Separation	29	29
Material Disintegration	28	28
Self-Activation or Keying	27	27
Component Missing	21	21
Intermittent Loss of Power	20	20
Material Separation	20	20
Premature Separation	20	20
Connection Problem	20	20
Physical Resistance/Sticking	17	17
Separation Problem	16	16
Smoking	16	16
Energy Output Problem	14	14
Display or Visual Feedback Problem	12	12
Device Alarm System	12	12
Defective Device	11	11
Incorrect Interpretation of Signal	11	11
Device Slipped	11	11
Unexpected Shutdown	11	11
Material Rupture	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Power Problem	10	10
Output Problem	9	9
Environmental Particulates	9	9
Unintended Ejection	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7835	7835
No Patient Involvement	2690	2690
No Consequences Or Impact To Patient	1349	1349
No Known Impact Or Consequence To Patient	257	257
Insufficient Information	114	114
Burn(s)	57	57
No Information	32	32
Superficial (First Degree) Burn	14	14
Partial thickness (Second Degree) Burn	12	12
Hemorrhage/Bleeding	9	9
Unspecified Tissue Injury	8	8
Foreign Body In Patient	5	5
Hearing Impairment	4	4
Unspecified Infection	3	3
Burn, Thermal	3	3
Bone Fracture(s)	2	2
Oversedation	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
Fatigue	1	1
Radiation Exposure, Unintended	1	1
Not Applicable	1	1
Dizziness	1	1
Sinus Perforation	1	1
Abrasion	1	1
Scarring	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
Tissue Damage	1	1
Full thickness (Third Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1