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TPLC
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Device
instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Regulation Description
Surgical instrument motors and accessories/attachments.
Product Code
HWE
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
3248
4035
2021
3140
3843
2022
3327
4019
2023
3399
4241
2024
3689
4962
2025
309
622
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
3776
3782
Complete Loss of Power
2977
2977
Mechanical Jam
2572
2572
Excessive Heating
1466
1466
Fracture
1368
2000
Break
1326
1332
Output below Specifications
984
984
Appropriate Term/Code Not Available
915
915
Detachment of Device or Device Component
896
1634
Noise, Audible
756
756
Failure to Cut
648
648
Unintended System Motion
610
611
Intermittent Loss of Power
552
552
Device-Device Incompatibility
436
436
Overheating of Device
287
429
Fluid/Blood Leak
239
742
Device Remains Activated
213
675
Mechanical Problem
206
207
Material Fragmentation
177
261
Naturally Worn
177
177
Material Disintegration
162
454
Leak/Splash
158
158
Device Slipped
156
156
Material Twisted/Bent
150
150
Vibration
142
142
Premature Separation
130
130
Fail-Safe Did Not Operate
120
346
Flaked
109
1360
Material Deformation
100
100
Entrapment of Device
99
99
Fail-Safe Problem
87
191
Corroded
79
79
Electrical /Electronic Property Problem
75
75
Defective Device
70
70
Adverse Event Without Identified Device or Use Problem
63
63
Difficult to Open or Close
54
206
Energy Output Problem
45
45
Crack
45
45
Unintended Movement
43
44
Material Integrity Problem
41
41
Compatibility Problem
36
36
Dull, Blunt
35
35
Unintended Power Up
31
37
Material Separation
30
30
Environmental Particulates
30
30
Material Split, Cut or Torn
29
29
Contamination /Decontamination Problem
28
28
Smoking
27
27
Component Missing
25
25
Device Reprocessing Problem
24
24
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13677
17976
No Consequences Or Impact To Patient
2274
2605
Insufficient Information
575
745
Foreign Body In Patient
337
338
No Patient Involvement
236
799
No Known Impact Or Consequence To Patient
153
254
Device Embedded In Tissue or Plaque
96
96
No Code Available
66
66
Burn(s)
41
41
Injury
26
26
Skin Tears
26
26
Not Applicable
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Unspecified Tissue Injury
16
16
No Information
15
28
Bone Fracture(s)
14
14
Superficial (First Degree) Burn
10
10
Unspecified Infection
6
6
Failure of Implant
6
6
Pain
5
5
Abrasion
4
4
Laceration(s)
4
4
Cardiac Perforation
4
4
Burn, Thermal
4
4
Brain Injury
3
3
Infiltration into Tissue
3
3
Full thickness (Third Degree) Burn
3
3
Tissue Damage
2
2
Perforation
2
2
Hemorrhage/Bleeding
2
2
Limb Fracture
1
1
Hypersensitivity/Allergic reaction
1
1
Hearing Impairment
1
1
Tinnitus
1
1
Nerve Damage
1
1
Swelling/ Edema
1
1
Rupture
1
1
Shock
1
1
Skin Discoloration
1
2
Patient Problem/Medical Problem
1
1
Arrhythmia
1
1
Non-union Bone Fracture
1
1
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