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TPLC
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show TPLC since
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2024
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Device
motor, surgical instrument, pneumatic powered
Product Code
GET
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
15
15
2020
15
15
2021
9
9
2022
13
13
2023
6
6
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
17
17
Detachment of Device or Device Component
15
15
Failure to Align
13
13
Material Split, Cut or Torn
10
10
Difficult to Open or Close
9
9
Mechanical Problem
6
6
Adverse Event Without Identified Device or Use Problem
3
3
Burst Container or Vessel
2
2
Unintended Ejection
2
2
Material Rupture
2
2
Excessive Heating
2
2
Overheating of Device
2
2
Entrapment of Device
1
1
Unintended Movement
1
1
Defective Component
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
36
36
No Consequences Or Impact To Patient
11
11
No Patient Involvement
6
6
No Known Impact Or Consequence To Patient
5
5
Insufficient Information
4
4
Unspecified Tissue Injury
3
3
Burn(s)
2
2
Death
1
1
Failure of Implant
1
1
Tinnitus
1
1
Partial thickness (Second Degree) Burn
1
1
Full thickness (Third Degree) Burn
1
1
No Information
1
1
No Code Available
1
1
Unintended Radiation Exposure
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Pro-Dex Inc
II
Apr-14-2023
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