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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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 8 8
2019 8 8
2020 11 11
2022 4 4
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 15 15
Mechanical Problem 12 12
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Detachment Of Device Component 3 3
Material Split, Cut or Torn 2 2
Bent 2 2
Difficult or Delayed Separation 1 1
Difficult to Open or Close 1 1
Material Twisted/Bent 1 1
Material Fragmentation 1 1
Delivered as Unsterile Product 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 19 19
No Known Impact Or Consequence To Patient 4 4
Pneumothorax 4 4
No Information 2 2
Insufficient Information 2 2
Foreign Body In Patient 1 1

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