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TPLC
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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
MDR Year
MDR Reports
MDR Events
2020
2369
2369
2021
2283
2283
2022
1574
1574
2023
1726
1726
2024
1589
1589
2025
421
421
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
Recalls
Manufacturer
Recall Class
Date Posted
1
Bien-Air Surgery Sa
II
Oct-21-2020
2
Medtronic Xomed, Inc.
II
Apr-20-2022
3
Medtronic Xomed, Inc.
II
Jul-21-2020
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