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TPLC
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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
INTERSCOPE, INC.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ ENDOSCOPY-AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
1
THE ANSPACH EFFORT, INC.
SUBSTANTIALLY EQUIVALENT
1
W&H DENTALWERK BUERMOSS GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1380
3606
2019
2515
2515
2020
2369
2369
2021
2283
2283
2022
1576
1576
2023
233
233
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
6134
7922
Device Remains Activated
631
661
Output below Specifications
581
581
Detachment of Device or Device Component
555
657
Excessive Heating
461
461
Fluid/Blood Leak
399
421
Noise, Audible
342
342
Unintended System Motion
307
307
Vibration
261
261
Break
234
238
Unintended Power Up
194
244
Leak/Splash
191
215
Fail-Safe Did Not Operate
175
175
Fail-Safe Problem
134
141
Flaked
128
136
Complete Loss of Power
117
117
Fracture
105
119
Material Twisted/Bent
104
137
Mechanical Jam
99
99
Material Fragmentation
95
111
Device Damaged by Another Device
92
92
Device-Device Incompatibility
64
64
Mechanical Problem
61
61
Appropriate Term/Code Not Available
43
43
Use of Device Problem
36
36
Disassembly
32
102
Unintended Movement
31
31
Material Separation
27
27
Smoking
25
29
Material Disintegration
24
29
Component Missing
21
21
Self-Activation or Keying
19
19
Physical Resistance/Sticking
18
27
Connection Problem
16
16
Material Rupture
14
14
Energy Output Problem
14
14
Intermittent Loss of Power
13
13
Separation Problem
11
11
Defective Device
11
11
Display or Visual Feedback Problem
11
11
Unstable
10
11
Difficult or Delayed Separation
9
9
Unexpected Shutdown
9
9
Output Problem
9
9
Power Problem
8
8
Unintended Ejection
8
8
Device Reprocessing Problem
7
7
Loose or Intermittent Connection
7
7
Collapse
6
6
Intermittent Continuity
6
6
Corroded
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Premature Separation
6
6
Device Operates Differently Than Expected
6
6
Environmental Particulates
6
6
Temperature Problem
5
5
Device Alarm System
5
5
Bent
5
44
Device Slipped
5
5
Failure to Power Up
4
4
Material Frayed
4
4
Sparking
4
4
Fitting Problem
3
3
Contamination /Decontamination Problem
3
3
Material Integrity Problem
3
3
Infusion or Flow Problem
3
3
Positioning Problem
3
13
Difficult To Position
3
3
Delivered as Unsterile Product
3
3
Metal Shedding Debris
3
5
Air Leak
2
2
Inability to Irrigate
2
2
Electrical /Electronic Property Problem
2
2
Detachment Of Device Component
2
3
Complete Blockage
2
2
Computer Software Problem
2
2
No Apparent Adverse Event
2
2
Material Deformation
2
2
Failure to Auto Stop
2
2
Device Operational Issue
2
2
Device Markings/Labelling Problem
2
2
Defective Component
2
2
Ambient Noise Problem
2
2
Blocked Connection
1
1
Deformation Due to Compressive Stress
1
1
Patient-Device Incompatibility
1
1
Device Or Device Fragments Location Unknown
1
1
Contamination of Device Ingredient or Reagent
1
1
Delamination
1
1
Compatibility Problem
1
1
Device Packaging Compromised
1
1
Difficult to Open or Close
1
1
Electrical Power Problem
1
1
Electrical Shorting
1
1
Environmental Compatibility Problem
1
1
Mechanics Altered
1
1
Naturally Worn
1
1
Insufficient Information
1
1
Intermittent Energy Output
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5310
5310
No Patient Involvement
3292
4216
No Consequences Or Impact To Patient
1897
2474
No Known Impact Or Consequence To Patient
503
1151
Burn(s)
54
250
Insufficient Information
40
40
No Information
38
42
Partial thickness (Second Degree) Burn
8
8
Therapeutic Effects, Unexpected
7
7
Superficial (First Degree) Burn
6
25
Hemorrhage/Bleeding
5
5
Foreign Body In Patient
4
4
Burn, Thermal
4
19
Unspecified Tissue Injury
4
4
Hearing Impairment
3
3
Bone Fracture(s)
2
2
Tissue Damage
2
2
Oversedation
2
2
Scarring
1
1
Shock
1
1
Intracranial Hemorrhage
1
1
Unspecified Infection
1
1
Cerebrospinal Fluid Leakage
1
1
Eye Injury
1
1
Abrasion
1
1
Arrhythmia
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Radiation Exposure, Unintended
1
1
Device Embedded In Tissue or Plaque
1
1
Not Applicable
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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