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TPLC
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Device
saw, powered, and accessories
Product Code
HAB
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
681
681
2019
676
676
2020
1462
1462
2021
1719
1719
2022
387
387
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
1962
1962
Mechanical Jam
1628
1628
Protective Measures Problem
357
357
Flaked
128
128
Noise, Audible
112
112
Break
84
84
Mechanical Problem
79
79
Temperature Problem
74
74
Material Fragmentation
66
66
Electrical Shorting
63
63
No Apparent Adverse Event
49
49
Insufficient Information
49
49
Physical Resistance/Sticking
48
48
Communication or Transmission Problem
47
47
Material Separation
38
38
Electrical /Electronic Property Problem
33
33
Appropriate Term/Code Not Available
30
30
Connection Problem
29
29
Unintended Power Up
28
28
Failure to Power Up
28
28
Device Inoperable
26
26
Adverse Event Without Identified Device or Use Problem
25
25
Self-Activation or Keying
24
24
Smoking
23
23
Device Displays Incorrect Message
23
23
Device Operates Differently Than Expected
22
22
Detachment of Device or Device Component
19
19
Material Deformation
19
19
Corroded
15
15
Melted
14
14
Metal Shedding Debris
14
14
Activation Problem
14
14
Failure to Cut
12
12
Loss of Power
12
12
Circuit Failure
11
11
Device Markings/Labelling Problem
11
11
Sparking
9
9
Material Twisted/Bent
9
9
Failure to Shut Off
9
9
Therapeutic or Diagnostic Output Failure
9
9
Thermal Decomposition of Device
9
9
Material Disintegration
9
9
Display or Visual Feedback Problem
8
8
Sticking
8
8
Defective Component
8
8
Dull, Blunt
8
8
Output Problem
8
8
Power Problem
8
8
Key or Button Unresponsive/not Working
8
8
Defective Device
8
8
Activation, Positioning or Separation Problem
7
7
Unexpected Shutdown
7
7
Intermittent Energy Output
7
7
Device Emits Odor
7
7
Fluid/Blood Leak
7
7
Material Frayed
6
6
Image Display Error/Artifact
6
6
Device Remains Activated
6
6
Material Integrity Problem
6
6
Device Contaminated During Manufacture or Shipping
5
5
Peeled/Delaminated
5
5
Material Discolored
5
5
Detachment Of Device Component
4
4
Unintended Ejection
4
4
Component Missing
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Failure to Auto Stop
4
4
Contamination /Decontamination Problem
4
4
Positioning Problem
4
4
Unintended Movement
4
4
Device Fell
3
3
Intermittent Loss of Power
3
3
Blocked Connection
3
3
Device-Device Incompatibility
3
3
Device Stops Intermittently
3
3
Partial Blockage
3
3
Leak/Splash
3
3
Loose or Intermittent Connection
3
3
Component Falling
3
3
Component Incompatible
2
2
Complete Blockage
2
2
Crack
2
2
Material Opacification
2
2
Energy Output Problem
2
2
Delivered as Unsterile Product
2
2
Premature Activation
2
2
Improper or Incorrect Procedure or Method
2
2
Vibration
2
2
Device Dislodged or Dislocated
2
2
Output below Specifications
2
2
Activation Failure
2
2
Complete Loss of Power
1
1
Firing Problem
1
1
Scratched Material
1
1
Packaging Problem
1
1
Unintended Electrical Shock
1
1
Separation Problem
1
1
Unclear Information
1
1
Excessive Heating
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2306
2306
No Known Impact Or Consequence To Patient
1390
1390
No Patient Involvement
906
906
No Information
184
184
No Consequences Or Impact To Patient
57
57
Foreign Body In Patient
27
27
Insufficient Information
25
25
Burn(s)
14
14
Injury
10
10
No Code Available
7
7
Device Embedded In Tissue or Plaque
6
6
Burn, Thermal
3
3
Unspecified Infection
3
3
Laceration(s)
3
3
Partial thickness (Second Degree) Burn
3
3
Pain
2
2
Capsular Contracture
2
2
Patient Problem/Medical Problem
2
2
Hemorrhage/Bleeding
2
2
Loss of Range of Motion
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Abrasion
2
2
Hematoma
1
1
Intracranial Hemorrhage
1
1
Inflammation
1
1
Unspecified Tissue Injury
1
1
Eye Injury
1
1
Forced Expiratory Volume Decreased
1
1
Post Operative Wound Infection
1
1
Scar Tissue
1
1
Adhesion(s)
1
1
Test Result
1
1
Full thickness (Third Degree) Burn
1
1
Fibrosis
1
1
Blister
1
1
Metal Related Pathology
1
1
Rupture
1
1
Muscle Weakness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrex, Inc.
II
Oct-30-2018
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