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TPLC
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Device
motor, surgical instrument, ac-powered
Regulation Description
Surgical instrument motors and accessories/attachments.
Product Code
GEY
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
952
952
2021
1145
1145
2022
1360
1360
2023
1444
1444
2024
1449
1449
2025
422
422
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
2673
2673
Complete Loss of Power
1752
1752
Excessive Heating
954
954
Appropriate Term/Code Not Available
548
548
Unintended System Motion
525
525
Mechanical Jam
493
493
Detachment of Device or Device Component
387
387
Intermittent Loss of Power
360
360
Noise, Audible
353
353
Device Alarm System
345
345
Material Fragmentation
326
326
Device-Device Incompatibility
231
231
Vibration
224
224
Output below Specifications
219
219
Break
207
207
Leak/Splash
169
169
Fail-Safe Did Not Operate
152
152
Device Slipped
113
113
Material Frayed
107
107
Fail-Safe Problem
75
75
Premature Separation
63
63
Fracture
61
61
Mechanical Problem
45
45
Difficult or Delayed Separation
41
41
Device Reprocessing Problem
39
39
Overheating of Device
36
36
Intermittent Energy Output
30
30
Electrical /Electronic Property Problem
21
21
Component Missing
21
21
Adverse Event Without Identified Device or Use Problem
20
20
Environmental Particulates
19
19
Packaging Problem
18
18
Circuit Failure
16
16
Energy Output Problem
13
13
Fluid/Blood Leak
12
12
Separation Failure
12
12
Corroded
11
11
Device Contaminated During Manufacture or Shipping
9
9
Unintended Movement
8
8
Improper or Incorrect Procedure or Method
8
8
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Separation Problem
7
7
Fire
6
6
Suction Failure
6
6
Connection Problem
6
6
Positioning Failure
4
4
Difficult to Open or Close
4
4
Contamination /Decontamination Problem
4
4
Failure to Cut
3
3
Device Markings/Labelling Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5912
5912
No Consequences Or Impact To Patient
799
799
No Known Impact Or Consequence To Patient
23
23
Osteolysis
7
7
Unspecified Tissue Injury
7
7
Bone Fracture(s)
6
6
Insufficient Information
6
6
Injury
5
5
Burn(s)
5
5
Embolism/Embolus
4
4
Limb Fracture
4
4
Foreign Body In Patient
3
3
Unspecified Infection
2
2
Post Operative Wound Infection
1
1
Headache
1
1
Blood Loss
1
1
Superficial (First Degree) Burn
1
1
Partial thickness (Second Degree) Burn
1
1
Not Applicable
1
1
No Code Available
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Laceration(s)
1
1
Nerve Damage
1
1
Tinnitus
1
1
Unspecified Musculoskeletal problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Pro-Dex Inc
II
Jul-05-2023
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