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 system, abortion, vacuum
Product CodeHHI
Regulation Number 884.5070
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2020 3 3
2021 3 3
2022 6 6
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Failure to Power Up 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Separation 1 1
Shipping Damage or Problem 1 1
Suction Problem 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Residue After Decontamination 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Device Fell 1 1
Failure to Clean Adequately 1 1
Device Reprocessing Problem 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 6 6
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 2 2
No Patient Involvement 2 2
Uterine Perforation 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
-
-