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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti fog solution and accessories, endoscopy
Regulation Description Endoscope and accessories.
Definition To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Product CodeOCT
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BATRIK MEDICAL MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
JDI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UV ONE HYGIENICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 16 16
2022 10 10
2023 13 13
2024 9 9
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 37 37
Defective Device 5 5
Break 2 2
Defective Component 2 2
Packaging Problem 2 2
Optical Obstruction 2 2
Improper or Incorrect Procedure or Method 2 2
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Material Discolored 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Flaked 1 1
Loss of or Failure to Bond 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Insufficient Information 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sunstar Americas, Inc. II Mar-03-2022
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