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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser for gastro-urology use
Product CodeLNK
Regulation Number 878.4810
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Partial Blockage 1 1
Computer Software Problem 1 1
No Display/Image 1 1
Image Orientation Incorrect 1 1
Leak/Splash 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Inadequate Pain Relief 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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