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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
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 1 1
2024 8 8
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Break 2 2
Mechanical Problem 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
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Pneumothorax 4 4
Hemorrhage/Bleeding 3 3
Perforation 2 2
Abdominal Pain 2 2
Foreign Body In Patient 2 2
Pancreatitis 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Vomiting 1 1
Fever 1 1

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