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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laryngostroboscope
Product CodeEQL
Regulation Number 874.4750
Device Class 1

MDR Year MDR Reports MDR Events
2017 5 5
2020 2 2
2021 3 3
2022 32 32
2023 25 25
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 34 34
No Display/Image 12 12
Erratic or Intermittent Display 9 9
Fluid/Blood Leak 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Optical Distortion 4 4
Optical Obstruction 4 4
Corroded 2 2
Sparking 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
Reaction 5 5
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company II Jun-28-2016
2 Pentax of America Inc II Jan-23-2017
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