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TPLC
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show TPLC since
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2020
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2024
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Device
system, abortion, vacuum
Product Code
HHI
Regulation Number
884.5070
Device Class
2
Premarket Reviews
Manufacturer
Decision
GYRUS ACMI
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
4
4
2016
1
1
2017
6
6
2018
5
5
2019
6
6
2020
3
3
2021
3
3
2022
6
6
2023
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8
8
Out-Of-Box Failure
3
3
Solder Joint Fracture
3
3
Break
3
3
Loose or Intermittent Connection
2
2
Insufficient Information
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Delivered as Unsterile Product
2
2
Device Contamination with Chemical or Other Material
2
2
Failure to Power Up
2
2
Pumping Stopped
1
1
Microbial Contamination of Device
1
1
Overfill
1
1
Device Reprocessing Problem
1
1
Suction Problem
1
1
Loss of Power
1
1
Fitting Problem
1
1
Increase in Suction
1
1
Crack
1
1
Device Markings/Labelling Problem
1
1
Device Fell
1
1
Failure to Clean Adequately
1
1
Physical Resistance
1
1
Misconnection
1
1
Packaging Problem
1
1
Residue After Decontamination
1
1
Material Separation
1
1
Device Operates Differently Than Expected
1
1
Device Contamination with Body Fluid
1
1
Shipping Damage or Problem
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hemorrhage/Bleeding
7
7
Blood Loss
6
6
No Patient Involvement
6
6
No Clinical Signs, Symptoms or Conditions
4
4
Hematoma
4
4
No Known Impact Or Consequence To Patient
4
4
Abdominal Pain
3
3
Foreign Body In Patient
3
3
Insufficient Information
3
3
Uterine Perforation
2
2
No Consequences Or Impact To Patient
2
2
Hypovolemic Shock
1
1
Unspecified Infection
1
1
Perforation
1
1
Partial thickness (Second Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Oct-17-2019
2
Richard Wolf Medical Instruments Corp.
II
Aug-19-2016
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