The RUMI System UML516Recalls & reported problems
Coopersurgical, Inc. · Disposable Uterine Manipulator Tip; Tip Diameter 5.1mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937001426), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Uterine Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.