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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, abortion, vacuum
Product CodeHHI
Regulation Number 884.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Solder Joint Fracture 3 3
Break 3 3
Out-Of-Box Failure 3 3
Loose or Intermittent Connection 2 2
Failure to Power Up 2 2
Device Contamination with Chemical or Other Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Insufficient Information 2 2
Device Fell 1 1
Failure to Clean Adequately 1 1
Packaging Problem 1 1
Residue After Decontamination 1 1
Overfill 1 1
Physical Resistance 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Pumping Stopped 1 1
Material Separation 1 1
Increase in Suction 1 1
Suction Problem 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Loss of Power 1 1
Device Contamination with Body Fluid 1 1
Device Reprocessing Problem 1 1
Crack 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 Known Impact Or Consequence To Patient 4 4
Hematoma 4 4
Abdominal Pain 3 3
Foreign Body In Patient 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
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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