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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device telescope, rigid, endoscopic
Product CodeFBP
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ENDOSERVICE OPTICAL INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2023 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Poor Quality Image 2 2
Use of Device Problem 1 1
Crack 1 1
No Display/Image 1 1
Fluid/Blood Leak 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 3 3
No Code Available 1 1
No Consequences Or Impact To Patient 1 1

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