The RUMI System UMG670Recalls & reported problems
Coopersurgical, Inc. · Disposable Uterine Manipulator Tip; Tip Diameter 6.7mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937001419), received between Dec 1, 2023 and Dec 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE METAL PORTION OF THE TIP CAME THROUGH THE TIP PORTION. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. UMG670. UTERINE TIP 2023-11-0000470.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18246059 ↗
Other Cannula, Manipulator/Injector, Uterine devices
- VCARE 60-6085-201AConmed Corporation · Cannula, manipulator/injector, uterine198 reports
- Cook G17147Cook Incorporated · Cannula, manipulator/injector, uterine68 reports
- Mckesson 11-19610Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- Mckesson 11-19611Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter with Integrated Stylet 61-4005SCoopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter • 5 French 61-4005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Catheter with Integrated Stylet • 5 French 61-3005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- VCARE 60-6085-202AConmed Corporation · Cannula, manipulator/injector, uterine46 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.