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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anoscope and accessories
Regulation Description Endoscope and accessories.
Definition To examine and perform procedures within the anus and rectum.
Product CodeFER
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES
  SUBSTANTIALLY EQUIVALENT 1
GASTRO CONCEPTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELL CARE (WUHAN) MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 18 18
2021 3 3
2022 3 3
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 11 11
Unintended Movement 9 9
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
No Apparent Adverse Event 4 4
Activation Failure 2 2
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Insufficient Information 1 1
Biocompatibility 1 1
Use of Device Problem 1 1
Activation, Positioning or Separation Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 6 6
No Code Available 3 3
Insufficient Information 2 2
Intracranial Hemorrhage 1 1
Blood Loss 1 1
No Information 1 1
Pain 1 1
Hemorrhage/Bleeding 1 1

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