RUMI II Koh-Efficient KC-RUMI-25Recalls & reported problems
Coopersurgical, Inc. · RUMI II Koh-Efficient- 2.5 cm for use with the RUMI II Handle · Class 2
All models of RUMI II Koh-Efficient (5)
Data updated Oct 16, 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 00888937015065), received between Apr 30, 2024 and Apr 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Abnormal Vaginal Discharge1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024Fracture; Fracture
PATIENT UNDERWENT LAPAROSCOPIC ACESSA ULTRASOUND GUIDED RADIOFREQUENCY FIBROID ABLATION, DIAGNOSTIC HYSTEROSCOPY, HYSTEROSCOPIC MYOMECTOMY, DIAGNOSTIC LAPAROSCOPY ON (B)(6) 2024. NO ISSUES AT TIME OF PROCEDURE. FOLLOW UP APPOINTMENT DUE TO INCREASED VAGINAL DISCHARGE. HARD PLASTIC BLUE OBJECT WEDGED DEEP IN VAGINA OVER CERVIX. FOREIGN BODY REMOVED BY PROVIDER MANUALLY WITH TWO-DIGIT EXAM. INSPECTED AND NOTED TO BE THE CERVICAL CAGE PORTION OF THE RUMI MANIPULATOR THAT WAS USED FOR ACESSA SURGERY. THE DISTAL PORTION OF THE RING OF THE MANIPULATOR APPEARED TO HAVE SNAPPED OFF OF THE REST OF THE RING DEVICE. NO INJURY TO PATIENT. KC-RUMI-25 KOH-EFFICIENT (B)(4).
Patient problems: Abnormal Vaginal Discharge
MAUDE report 19215913 ↗
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
- GelPOINT V-Path C2A15Applied Medical Resources Corporation · Culdoscope (And Accessories)4 reports
- Arch Koh-Efficient KC-ARCH-35Coopersurgical, Inc. · Culdoscope (And Accessories)4 reports
- Arch Koh-Efficient KC-ARCH-30Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- USA Series G27L-30WAGyrus ACMI, LLC · Culdoscope (And Accessories)3 reports
- Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® AD750-KE35Coopersurgical, Inc. · 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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