RUMI II Reusable Uterine Manipulator Handle UMH650Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937015232), received between Mar 25, 2021 and Feb 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2023Mechanical Problem; Mechanical Problem

  AFTER PLACING THE RUMI W/ATTACHMENT IN PATIENT, THE HANDLE FELL APART AND THE MISSING PART HAD TO BE RETRIEVED FROM PATIENT. RUMI II BACKLOADABLE UMH650 E-COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402625 ↗
• MalfunctionMar 25, 2021Break

  DURING A SURGICAL PROCEDURE (XI ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY WITH MESH WITH SINGLE INCISION SUBURETHRAL SLING) THE GYN SURGEON REQUESTED FOR ADDITIONAL MANIPULATION. THE PEDAL WAS LOOSE AND THE SPRING BROKE FROM THE RUMI HANDLE. THE CERTIFIED SURGICAL TECHNICIAN (CST) WAS THEN REQUESTED TO LOWER THE HANDLE THUS LIFTING THE UTERUS AND THE CST'S ARM GOT CAUGHT THE ALLY AND THE OR TABLE. 1216677-2021-00050-1 RUMI II BACKLOADABLE UMH650 (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 11569765 ↗