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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, 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 CodeBWH
Regulation Number 874.4680
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 2 2
Physical Resistance/Sticking 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Foreign Body In Patient 1 1

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