The RUMI System UMW676Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937001440), received between Apr 23, 2020 and Aug 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 3, 2020Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem; Physical Resistance/Sticking

  PER MEDWATCH 5095205- "PATIENT WAS ADMITTED FOR ROBOTIC LAPAROSCOPIC FULGURATION WITH EXCISION OF LESION, SMALL TIP IN THE UTERUS AT SPECIFIC POINT IN THE PROCEDURE, THE SURGEON INSTRUCTED THE SURGICAL TECH TO INSTILL METHYLENE BLUE INTO THE DYE PORT ON THE RUMI. ROBOTIC SURGERIES ARE OFTEN DONE IN THE DARK AND COOPER SURGICAL RUMI PORTS HAVE NO DIFFERENTIATION. THEY LOOK EXACTLY THE SAME WITH UNIVERSAL CONNECTIVITY WHICH CAUSED THE TECH TO CHOOSE WRONG PORT. HE TRIED TO INSTILL THE DYE WHEN SHE MET RESISTANCE, SHE ESCALATED TO THE SURGEON. THE SURGEON INSTRUCTED HET TO TRY AGAIN, SHE MET RESISTANCE THE SECOND TIME AFTER WHICH THE ASSISTANT SURGEON ENTERED INTO THE SURGICAL ARENA, HE ATTEMPTED TO INSTILL THE DYE AND IT WENT INTO THE UTERINE BALLOON CAUSING IT TO RUPTURE THE UTERUS. A 3CM RENT WAS NOTICED AFTER DEFLATING THE RUMI. IT WAS NOTED AT THE TIME AND SUBSEQUENT TO PROCEDURE THAT TWO PORTS DO NOT DIFFERENTIATE IN COLOR OR CONNECTIVITY WHICH LENDS ITSELF TO CONFUSION DURING THE PROCEDURE". UMW676 UTERINE MANIPULATOR TIP W (B)(4).

  Patient problems: Rupture

  MAUDE report 10357328 ↗
• MalfunctionApr 23, 2020Burst Container or Vessel

  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". 1216677-2020-00096-1, UMW676 UTERINE MANIPULATOR TIP W E-COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993097 ↗