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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
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
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 4 4
2019 15 15
2020 18 18
2021 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 13 13
Unintended Movement 8 8
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Detachment Of Device Component 4 4
Use of Device Problem 4 4
Suction Problem 3 3
Difficult or Delayed Positioning 3 3
No Apparent Adverse Event 3 3
Activation Failure 2 2
Activation, Positioning or SeparationProblem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Defective Device 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Break 1 1
Material Fragmentation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Perforation 1 1
Improper or Incorrect Procedure or Method 1 1
Unclear Information 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21 21
No Consequences Or Impact To Patient 13 13
No Clinical Signs, Symptoms or Conditions 12 12
No Code Available 3 3
Insufficient Information 2 2
Skin Tears 1 1
Blood Loss 1 1
No Patient Involvement 1 1
No Information 1 1
Hemorrhage/Bleeding 1 1
Intracranial Hemorrhage 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Nov-21-2019
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