RUMI II Koh-Efficient KCS-RUMI-35Recalls & reported problems
Coopersurgical, Inc. · RUMI II Koh-Efficient- 3.5 cm for use with the RUMI II Handle - Harmonic scalpel and laser · Class 2
All models of RUMI II Koh-Efficient (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00888937015126), received between Aug 8, 2024 and Aug 8, 2024 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024
THE SURGEON ASSEMBLED THE MANIPULATOR PRIOR TO INSERTION, AND INSPECTED IT AGAIN ON REMOVAL AND NOTED THAT THE CUP WAS NOT ATTACHED. MANUFACTURER RESPONSE FOR CULDOSCOPE (AND ACCESSORIES), RUMI II KOH-EFFICIENT (PER SITE REPORTER). THEY HAVE OPENED AN INVESTIGATION AND ARE WORKING WITH THE HOSPITAL TO COMPLETE THEIR INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 19937665 ↗
Other Culdoscope (And Accessories) devices
- GelPOINT V-Path C2A12Applied Medical Resources Corporation · Culdoscope (And Accessories)24 reports
- RUMI II Koh-Efficient KC-RUMI-30Coopersurgical, Inc. · Culdoscope (And Accessories)12 reports
- RUMI II Koh-Efficient KC-RUMI-35Coopersurgical, Inc. · Culdoscope (And Accessories)8 reports
- Arch Koh-Efficient KC-ARCH-35Coopersurgical, Inc. · Culdoscope (And Accessories)4 reports
- GelPOINT V-Path C2A15Applied Medical Resources Corporation · Culdoscope (And Accessories)4 reports
- Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® AD750-KE35Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- Arch Koh-Efficient KC-ARCH-30Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- USA Series G27L-30WAGyrus ACMI, LLC · Culdoscope (And Accessories)3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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