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TPLC
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Device
photocoagulator and accessories
Regulation Description
Ophthalmic photocoagulator.
Product Code
HQB
Regulation Number
886.4690
Device Class
2
Premarket Reviews
Manufacturer
Decision
VORTEX SURGICAL INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
14
14
2021
1
1
2022
3
3
2023
3
3
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Deliver Energy
3
3
Insufficient Information
2
2
Fitting Problem
2
2
Firing Problem
2
2
Device Operational Issue
2
2
Mechanical Problem
2
2
Gas/Air Leak
2
2
Appropriate Term/Code Not Available
2
2
Incomplete or Missing Packaging
1
1
Lack of Effect
1
1
Ejection Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Detachment of Device or Device Component
1
1
Loose or Intermittent Connection
1
1
Unintended Ejection
1
1
Break
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
8
8
No Clinical Signs, Symptoms or Conditions
7
7
Pain
4
4
No Code Available
3
3
Radiation Exposure, Unintended
2
2
Awareness during Anaesthesia
2
2
Insufficient Information
1
1
Eye Burn
1
1
Eye Injury
1
1
Conjunctivitis
1
1
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