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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light source system, diagnostic endoscopic
Definition A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.
Product CodeOAY
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 2 0 3 1 2 0 0 3 3 4 6 3 2 1 0

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2022 2 2
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2 2
Misassembly by Users 2 2
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1
Smoking 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 2 2
Needle Stick/Puncture 2 2
Superficial (First Degree) Burn 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Burn, Thermal 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy America Inc II May-08-2013
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