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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
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
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