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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brush, biopsy, bronchoscope (non-rigid)
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeBTG
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
HOBBS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 11 11
2022 4 4
2023 1 1
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 14 14
Mechanical Problem 13 13
Break 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 1 1
Delivered as Unsterile Product 1 1
Difficult or Delayed Separation 1 1
Retraction Problem 1 1
Material Separation 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
Pneumothorax 4 4
Perforation 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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