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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
2019
1131
1131
2020
952
952
2021
1145
1145
2022
1360
1360
2023
1444
1444
2024
374
374
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
2070
2070
Complete Loss of Power
1296
1296
Excessive Heating
830
830
Mechanical Jam
679
679
Unintended System Motion
517
517
Detachment of Device or Device Component
431
431
Noise, Audible
375
375
Appropriate Term/Code Not Available
347
347
Intermittent Loss of Power
294
294
Device Alarm System
277
277
Material Fragmentation
270
270
Vibration
200
200
Output below Specifications
193
193
Device-Device Incompatibility
181
181
Break
177
177
Leak/Splash
164
164
Fail-Safe Did Not Operate
117
117
Intermittent Energy Output
107
107
Material Frayed
99
99
Unexpected Shutdown
83
83
Device Slipped
77
77
Overheating of Device
73
73
Fail-Safe Problem
63
63
Fracture
62
62
Fluid/Blood Leak
60
60
Positioning Problem
57
57
Premature Separation
40
40
Mechanical Problem
37
37
Device Reprocessing Problem
32
32
Difficult or Delayed Separation
31
31
Adverse Event Without Identified Device or Use Problem
25
25
Packaging Problem
17
17
Loose or Intermittent Connection
16
16
Environmental Particulates
16
16
Electrical /Electronic Property Problem
14
14
Circuit Failure
14
14
Component Missing
14
14
Separation Failure
12
12
Device Contaminated During Manufacture or Shipping
9
9
Material Twisted/Bent
9
9
Energy Output Problem
8
8
Difficult to Remove
7
7
Unintended Movement
7
7
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Crack
6
6
Corroded
6
6
Connection Problem
6
6
Improper or Incorrect Procedure or Method
5
5
Fire
5
5
Separation Problem
5
5
Suction Failure
4
4
Difficult to Open or Close
4
4
Failure to Cut
3
3
Premature Discharge of Battery
3
3
Contamination /Decontamination Problem
3
3
Device Markings/Labelling Problem
3
3
Device Damaged by Another Device
3
3
Positioning Failure
3
3
Material Deformation
3
3
Peeled/Delaminated
2
2
Failure to Clean Adequately
2
2
Difficult to Insert
2
2
Poor Visibility
2
2
Use of Device Problem
2
2
Suction Problem
2
2
Unintended Ejection
2
2
Compatibility Problem
2
2
Material Integrity Problem
1
1
Battery Problem
1
1
Unintended Electrical Shock
1
1
Infusion or Flow Problem
1
1
No Apparent Adverse Event
1
1
Particulates
1
1
Melted
1
1
Insufficient Heating
1
1
Chemical Problem
1
1
Intermittent Continuity
1
1
Explosion
1
1
Device Displays Incorrect Message
1
1
Unraveled Material
1
1
Device Damaged Prior to Use
1
1
Material Rupture
1
1
Scratched Material
1
1
Mechanics Altered
1
1
Decrease in Suction
1
1
Dull, Blunt
1
1
Dent in Material
1
1
Electrical Shorting
1
1
Pumping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4423
4423
No Consequences Or Impact To Patient
1586
1586
No Known Impact Or Consequence To Patient
350
350
Bone Fracture(s)
9
9
Osteolysis
7
7
Foreign Body In Patient
6
6
Unspecified Tissue Injury
5
5
Insufficient Information
5
5
Injury
5
5
Burn(s)
4
4
No Code Available
4
4
Embolism/Embolus
4
4
Limb Fracture
4
4
Not Applicable
3
3
Abrasion
2
2
Tissue Damage
2
2
Unspecified Infection
2
2
Laceration(s)
1
1
Nerve Damage
1
1
Skin Irritation
1
1
Tingling
1
1
Partial thickness (Second Degree) Burn
1
1
Post Operative Wound Infection
1
1
Electric Shock
1
1
Blood Loss
1
1
No Patient Involvement
1
1
Superficial (First Degree) Burn
1
1
Unspecified Musculoskeletal problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Pro-Dex Inc
II
Jul-05-2023
2
Pro-Dex Inc
II
Aug-22-2019
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