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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photocoagulator and accessories
Product CodeHQB
Regulation Number 886.4690
Device Class 2


Premarket Reviews
ManufacturerDecision
VITREQ B.V.
  SUBSTANTIALLY EQUIVALENT 1
VORTEX SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
VORTEX SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 3 3
2019 1 1
2020 14 14
2021 1 1
2022 3 3
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4 4
Firing Problem 4 4
Device Operational Issue 3 3
Gas/Air Leak 3 3
Break 3 3
Failure to Deliver Energy 3 3
Fitting Problem 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Ejection Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incomplete or Missing Packaging 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Unintended Ejection 1 1
Loose or Intermittent Connection 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 6 6
Pain 4 4
No Code Available 3 3
No Known Impact Or Consequence To Patient 3 3
Radiation Exposure, Unintended 2 2
Awareness during Anaesthesia 2 2
Conjunctivitis 1 1
Eye Injury 1 1
Eye Burn 1 1
No Information 1 1

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