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TPLC
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Device
instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Product Code
HWE
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
3452
4249
2020
3248
4035
2021
3140
3843
2022
3327
4019
2023
3399
4241
2024
777
1054
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
3270
3350
Mechanical Jam
2609
2609
Complete Loss of Power
2488
2488
Output below Specifications
1605
1605
Fracture
1525
2128
Excessive Heating
1277
1277
Break
1271
1301
Noise, Audible
954
954
Detachment of Device or Device Component
902
1596
Unintended System Motion
742
742
Appropriate Term/Code Not Available
636
636
Failure to Cut
498
498
Intermittent Loss of Power
475
475
Overheating of Device
408
591
Device-Device Incompatibility
371
371
Fluid/Blood Leak
289
825
Device Remains Activated
220
802
Unexpected Shutdown
175
175
Vibration
161
161
Material Fragmentation
149
234
Material Disintegration
146
374
Leak/Splash
145
145
Material Twisted/Bent
139
139
Intermittent Energy Output
131
131
Naturally Worn
128
128
Device Slipped
115
115
Premature Separation
107
107
Mechanical Problem
106
108
Fail-Safe Problem
103
242
Entrapment of Device
99
99
Fail-Safe Did Not Operate
92
121
Flaked
90
791
Material Deformation
72
73
Crack
68
68
Adverse Event Without Identified Device or Use Problem
67
67
Corroded
56
56
Material Separation
56
56
Defective Device
52
52
Difficult to Open or Close
50
240
Unintended Power Up
40
48
Energy Output Problem
39
39
Unintended Movement
38
38
Dull, Blunt
37
37
Material Integrity Problem
37
37
Compatibility Problem
30
30
Smoking
28
28
Electrical /Electronic Property Problem
27
27
Contamination /Decontamination Problem
23
23
Environmental Particulates
23
23
Difficult or Delayed Separation
21
21
Component Missing
20
20
Difficult to Remove
19
19
Device Emits Odor
19
19
Device Reprocessing Problem
18
18
Material Split, Cut or Torn
17
17
Use of Device Problem
15
15
Connection Problem
15
15
Separation Problem
15
15
Degraded
14
14
No Apparent Adverse Event
13
13
Device Markings/Labelling Problem
13
13
Positioning Failure
13
13
Fitting Problem
12
12
Circuit Failure
12
12
Fire
12
12
Improper or Incorrect Procedure or Method
12
12
Power Problem
11
11
Defective Component
11
11
Device Damaged by Another Device
11
11
Protective Measures Problem
10
10
Loose or Intermittent Connection
10
10
Insufficient Information
10
10
Key or Button Unresponsive/not Working
10
10
Unintended Ejection
9
10
Packaging Problem
9
9
Output Problem
8
8
Difficult to Insert
8
8
Manufacturing, Packaging or Shipping Problem
7
7
Positioning Problem
7
7
Delivered as Unsterile Product
7
50
Tear, Rip or Hole in Device Packaging
7
7
Failure to Cycle
6
6
Scratched Material
6
6
Temperature Problem
6
6
Separation Failure
6
6
Failure to Power Up
5
5
Loosening of Implant Not Related to Bone-Ingrowth
5
5
Display or Visual Feedback Problem
5
5
Communication or Transmission Problem
5
5
Contamination
5
5
Failure to Auto Stop
5
5
Therapeutic or Diagnostic Output Failure
4
4
Device Dislodged or Dislocated
3
3
Activation, Positioning or Separation Problem
3
3
Material Puncture/Hole
3
3
Structural Problem
3
3
Melted
3
3
Explosion
3
3
Sparking
3
3
Failure to Shut Off
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
10732
13767
No Consequences Or Impact To Patient
4562
5319
No Known Impact Or Consequence To Patient
905
1301
No Patient Involvement
511
1561
Foreign Body In Patient
353
353
Insufficient Information
292
400
Device Embedded In Tissue or Plaque
112
112
Not Applicable
99
99
No Code Available
91
91
Burn(s)
48
48
No Information
42
106
Injury
31
31
Skin Tears
26
26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Unspecified Tissue Injury
15
15
Bone Fracture(s)
15
15
Superficial (First Degree) Burn
9
9
Pain
8
8
Unspecified Infection
8
8
Failure of Implant
7
7
Laceration(s)
6
6
Tissue Damage
6
6
Abrasion
4
4
Cardiac Perforation
4
4
Burn, Thermal
4
4
Patient Problem/Medical Problem
3
3
Infiltration into Tissue
3
3
Brain Injury
3
3
Full thickness (Third Degree) Burn
2
2
Hemorrhage/Bleeding
2
2
Perforation
2
2
Skin Irritation
2
2
Sprain
1
1
Rupture
1
1
Nerve Damage
1
1
Tinnitus
1
1
Swelling/ Edema
1
1
Damage to Ligament(s)
1
1
Non-union Bone Fracture
1
1
Limb Fracture
1
1
Alteration In Body Temperature
1
1
Skin Discoloration
1
2
Hearing Impairment
1
1
Arrhythmia
1
1
Shock
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Encore Medical, Lp
II
Jul-27-2019
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