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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)
Regulation Description Bronchoscope (flexible or rigid) and accessories.
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
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 17 17
Mechanical Problem 13 13
Adverse Event Without Identified Device or Use Problem 5 5
Break 2 2
Material Fragmentation 2 2
Material Split, Cut or Torn 1 1
Use of Device Problem 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 10 10
Pneumothorax 4 4
Hemorrhage/Bleeding 3 3
Abdominal Pain 2 2
Pancreatitis 2 2
Perforation 2 2
Foreign Body In Patient 2 2
Insufficient Information 2 2
Fever 1 1
Vomiting 1 1
Device Embedded In Tissue or Plaque 1 1

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