Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
ANGIOLOGICA B. M. SRL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON ENDO-SURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
OBP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THD SPA
  SUBSTANTIALLY EQUIVALENT 4
WELL CARE (WUHAN) MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 14 26
2017 4 4
2018 4 4
2019 15 15
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 18 18
Detachment Of Device Component 13 25
Unintended Movement 9 9
Detachment of Device or Device Component 8 8
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Suction Problem 3 3
Difficult or Delayed Positioning 3 3
Break 3 3
Activation, Positioning or Separation Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Fragmentation 2 2
Activation Failure 2 2
Unclear Information 1 1
Insufficient Information 1 1
Output Problem 1 1
Temperature Problem 1 1
Torn Material 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
Defective Device 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Gas/Air Leak 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 20 20
No Clinical Signs, Symptoms or Conditions 19 19
No Code Available 5 5
No Information 3 3
Insufficient 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
-
-