The RUMI System UMB678Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888937001402), received between Dec 27, 2017 and Dec 16, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2022Material Puncture/Hole; Material Puncture/Hole

  MANIPULATING UTERUS AS USUAL AND NOTICED METAL PIECE PROTRUDING THROUGH SIDE OF UTERUS ONCE IN ABDOMEN. COLORECTAL SURGEON PLACED A FEW STITCHES IN MUCOSAL LINING, COLONOSCOPY PERFORMED, NO VISIBLE PERFORATION. ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? NO MEDICAL OR PROCEDURAL INTERVENTION? YES 1216677-2022-00335 UMB678 UTERINE MANIPULATOR TIP B E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000216 ↗
• MalfunctionOct 1, 2021Break

  CUSTOMER STATED: "PLASTIC RUMI TIP BROKE WHILE MANIPULATING THE UTERUS CAUSING UTERINE PERFORMATION WHICH WAS NEAR THE BOWL". UMB678 UTERINE MANIPULATOR TIP B (B)(4).

  Patient problems: Perforation

  MAUDE report 12563162 ↗
• MalfunctionApr 19, 2021Break; Entrapment of Device; Fluid/Blood Leak; Fracture; Inflation Problem

  THE TIP WAS BROKEN FROM THE WHITE BASE AND IT REMAINED INSIDE THE PATIENT'S UTERUS.WHEN THEY WERE TRYING TO FILL THE BALLOON, THE SALINE SOLUTIONS WAS DRIPPING AND THEY WERE UNABLE TO INFLATE. THE TIP WAS ALREADY INSIDE THE PATIENT. THEY REMOVED THE TIP AND REPLACED IT WITH ANOTHER ONE THAT WORKED WELL. UTERINE MANIPULATOR TIP B UMB678 (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11686544 ↗
• MalfunctionMar 25, 2021Defective Component

  CUSTOMER STATED: "METAL WIRE TORE THROUGH TIP AND ENDED UP IN THE BLADDER. PATIENT STATUS-HAD TO SUTURE A DEFECT IN THE BLADDER". 1216677-2021-00052-1 UMB678 UTERINE MANIPULATOR TIP B (B)(4)

  Patient problems: Foreign Body In Patient

  MAUDE report 11570719 ↗
• MalfunctionOct 9, 2020Material Separation

  REPORT STATED: "BLUE COLPOTOMY PART OF KOH CUP SEPARATED DURING ROBOTIC TOTAL HYSTERECTOMY AND WAS LEFT REMAINING INSIDE OF PATIENT. COLPOTOMY CUP WAS RECOVERED BEFORE CASE ENDED, AND ENTIRE LOT HAS BEEN SEQUESTERED". 1216677-2020-00228-1 UMB678 UTERINE MANIPULATOR TIP B E-(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10655521 ↗
• MalfunctionApr 23, 2020Break

  REPORT STATED: "BALLOON EXPLODED WHEN SURGEON INFLATED WITH NORMAL SALINE. DURING LAPAROSCOPIC MYOMECTOMY + OVARIAN CYSTECTOMY + HYSTEROSCOPY. CHECKED FOR THE COMPLETENESS OF THE BALLOON AND SEARCHED - NO FOREIGN BODY REMAINED IN PATIENT BODY". 1216677-2020-00095-1 UMB678 UTERINE MANIPULATOR TIP B E-COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9990235 ↗
• MalfunctionDec 27, 2017Malposition of Device; Torn Material

  (B)(4). "THE COLOURED SILICONE TUBING OF THE DISPOSABLE UTERINE MANIPULATOR TIP RIPPED OFF THE INTERNAL METAL POST EXPOSING THE INTERNAL METAL TIP. THE METAL TIP PUNCTURED THROUGH THE UTERUS AND BOWEL CAUSING A BOWEL TEAR. THE TEAR WAS REPAIRED."

  Patient problems: Tissue Damage; Uterine Perforation

  MAUDE report 7148903 ↗