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TPLC
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show TPLC since
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Device
motor, surgical instrument, ac-powered
Product Code
GEY
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
1288
1288
2019
1131
1131
2020
952
952
2021
1146
1146
2022
1361
1361
2023
467
467
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
1550
1550
Mechanical Jam
986
986
Complete Loss of Power
916
916
Unintended System Motion
694
694
Excessive Heating
653
653
Noise, Audible
423
423
Detachment of Device or Device Component
399
399
Fail-Safe Problem
256
256
Material Fragmentation
235
235
Intermittent Loss of Power
220
220
Device Alarm System
174
174
Output below Specifications
168
168
Appropriate Term/Code Not Available
161
161
Vibration
151
151
Intermittent Energy Output
142
142
Overheating of Device
138
138
Device-Device Incompatibility
137
137
Leak/Splash
134
134
Fluid/Blood Leak
129
129
Break
125
125
Unexpected Shutdown
111
111
Material Frayed
65
65
Fail-Safe Did Not Operate
63
63
Positioning Problem
62
62
Device Operates Differently Than Expected
57
57
Device Stops Intermittently
51
51
Fracture
49
49
Device Slipped
48
48
Mechanical Problem
41
41
Loose or Intermittent Connection
30
30
Device Inoperable
30
30
Premature Separation
28
28
Difficult or Delayed Separation
23
23
Adverse Event Without Identified Device or Use Problem
23
23
Connection Problem
23
23
Material Twisted/Bent
21
21
Device Reprocessing Problem
20
20
Detachment Of Device Component
19
19
Packaging Problem
17
17
Material Deformation
10
10
Circuit Failure
10
10
Difficult to Remove
10
10
Electrical /Electronic Property Problem
9
9
Environmental Particulates
9
9
Contamination /Decontamination Problem
8
8
Component Missing
8
8
Separation Failure
8
8
Incomplete or Inadequate Connection
8
8
Crack
7
7
Energy Output Problem
6
6
Device Contaminated During Manufacture or Shipping
6
6
Device Operational Issue
5
5
Difficult to Open or Close
4
4
Defective Component
4
4
Material Separation
4
4
Peeled/Delaminated
4
4
Difficult To Position
4
4
Corroded
4
4
Separation Problem
4
4
Failure to Clean Adequately
4
4
Power Problem
3
3
Unintended Movement
3
3
Premature Discharge of Battery
3
3
Difficult to Insert
3
3
Device Damaged by Another Device
3
3
Failure to Disconnect
3
3
Dent in Material
2
2
Device Markings/Labelling Problem
2
2
Electrical Shorting
2
2
Device Contamination with Chemical or Other Material
2
2
Use of Device Problem
2
2
Smoking
2
2
Suction Problem
2
2
Dull, Blunt
2
2
Positioning Failure
2
2
Loss of Power
2
2
Suction Failure
2
2
Naturally Worn
2
2
No Fail-Safe Mechanism
1
1
Operating System Becomes Nonfunctional
1
1
Pumping Problem
1
1
Reset Problem
1
1
Scratched Material
1
1
Temperature Problem
1
1
Mechanics Altered
1
1
Material Integrity Problem
1
1
Failure of Device to Self-Test
1
1
Unintended Electrical Shock
1
1
Misassembly by Users
1
1
No Apparent Adverse Event
1
1
Device Handling Problem
1
1
Explosion
1
1
Material Rupture
1
1
No Device Output
1
1
Particulates
1
1
Insufficient Heating
1
1
Melted
1
1
Intermittent Continuity
1
1
Complete Blockage
1
1
Air Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3089
3089
No Consequences Or Impact To Patient
2501
2501
No Known Impact Or Consequence To Patient
702
702
No Patient Involvement
15
15
Not Applicable
10
10
Bone Fracture(s)
9
9
Foreign Body In Patient
6
6
Injury
5
5
Burn(s)
4
4
No Code Available
4
4
Embolism/Embolus
4
4
Limb Fracture
4
4
Insufficient Information
3
3
Unspecified Tissue Injury
2
2
Abrasion
2
2
Unspecified Infection
2
2
Laceration(s)
2
2
Post Operative Wound Infection
2
2
Tissue Damage
2
2
Tingling
1
1
Superficial (First Degree) Burn
1
1
Electric Shock
1
1
Blood Loss
1
1
Nerve Damage
1
1
Skin Irritation
1
1
Hemorrhage/Bleeding
1
1
No Information
1
1
Partial thickness (Second Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Pro-Dex Inc
II
Aug-22-2019
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