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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
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 14 26
2017 4 4
2018 4 4
2019 15 15
2020 18 18
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 13 25
Patient-Device Incompatibility 12 12
Unintended Movement 7 7
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Use of Device Problem 4 4
Suction Problem 3 3
Difficult or Delayed Positioning 3 3
Activation, Positioning or SeparationProblem 3 3
Activation Failure 2 2
No Apparent Adverse Event 2 2
Break 2 2
Tear, Rip or Hole in Device Packaging 2 2
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Output Problem 1 1
Temperature Problem 1 1
Torn Material 1 1
Material Fragmentation 1 1
Difficult to Remove 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Perforation 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Information 1 1
Gas Leak 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 38
No Consequences Or Impact To Patient 19 19
No Clinical Signs, Symptoms or Conditions 10 10
No Code Available 5 5
Insufficient Information 2 2
No Information 2 2
Skin Tears 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Burn(s) 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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