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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reprocessed bronchoscope
Definition Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission.
Product CodeQNW
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
AURIS HEALTH INC., A JOHNSON AND JOHNSON FAMILY COMPANY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 7 7
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
No Display/Image 3 3
No Apparent Adverse Event 2 2
Poor Quality Image 1 1
Difficult to Remove 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Pneumothorax 4 4
Laceration(s) of Esophagus 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1

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