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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device esophagoscope, general & plastic surgery
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 CodeGCL
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 9 9
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 8 8
No Display/Image 3 3
Break 2 2
Erratic or Intermittent Display 2 2
Obstruction of Flow 1 1
Optical Distortion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

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