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TPLC
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Device
anoscope and accessories
Definition
To examine and perform procedures within the anus and rectum.
Product Code
FER
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Adverse Event Without Identified Device or Use Problem
4
4
No Apparent Adverse Event
4
4
Difficult or Delayed Positioning
3
3
Break
3
3
Suction Problem
3
3
Activation, Positioning or Separation Problem
2
2
Material Fragmentation
2
2
Tear, Rip or Hole in Device Packaging
2
2
Activation Failure
2
2
Improper or Incorrect Procedure or Method
1
1
Gas/Air Leak
1
1
Temperature Problem
1
1
Biocompatibility
1
1
Output Problem
1
1
Torn Material
1
1
Insufficient Information
1
1
Unclear Information
1
1
Defective Device
1
1
Difficult to Remove
1
1
Contamination /Decontamination Problem
1
1
Material Perforation
1
1
Inadequacy of Device Shape and/or Size
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
Blood Loss
1
1
Burn(s)
1
1
Intracranial Hemorrhage
1
1
No Patient Involvement
1
1
Pain
1
1
Skin Tears
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Applied Medical Resources Corp
II
Nov-21-2019
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