RUMI II Koh-Efficient KC-RUMI-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888937015072), received between Oct 12, 2018 and Apr 7, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DISPOSABLE RUMI CUP WAS USED. THE DISPOSABLE COMPONENT WAS VERY DIFFICULT TO REMOVE FROM THE NON-DISPOSABLE HANDLE. IN THE PROCESS FOR REMOVAL, THE SHARP PLASTIC COMPONENT CUT THE SURGEON'S THUMB - THROUGH THE GLOVE AND CUT THROUGH SKIN. THIS WAS DUE TO THE INSTRUMENT ITSELF. THE DISPOSABLE RUMI CUP NEEDS TO BE REMOVED FROM THE RE-USEABLE COMPONENT AT THE END OF EACH CASE. DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE. 1216677-2026-00027 KC-RUMI-35 KOH-EFFICIENT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 24802579 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MYOMECTOMY IN (B)(6) 2025. IT WAS DISCOVERED DURING A OFFICE VISIT CHECK-UP THAT THE KOH CUP WAS REMAINING IN THE VAGINAL CAVITY AND IT WAS SUBSEQUENTLY REMOVED. NO HARM WAS REPORTED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. KC-RUMI-30 KOH-EFFICIENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365185 ↗
• MalfunctionDec 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760007 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 3/3 IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RUMI KOH-EFFICIENT WAS USED AND LACERATED THE VAGINAL WALL. NO OBVIOUS DEFECT IN THE DEVICE WAS FOUND. SUTURES WERE REQUIRED TO STOP BLEEDING. NO ADDITIONAL INFORMATION IS AVAILABLE. KC-RUMI-30 KOH-EFFICIENT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 20089358 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 2/3. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RUMI KOH-EFFICIENT WAS USED AND LACERATED THE VAGINAL WALL. NO OBVIOUS DEFECT IN THE DEVICE WAS FOUND. SUTURES WERE REQUIRED TO STOP BLEEDING. NO ADDITIONAL INFORMATION IS AVAILABLE. KC-RUMI-30 KOH-EFFICIENT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 20089218 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RUMI KOH-EFFICIENT WAS USED AND LACERATED THE VAGINAL WALL. NO OBVIOUS DEFECT IN THE DEVICE WAS FOUND. SUTURES WERE REQUIRED TO STOP BLEEDING. NO ADDITIONAL INFORMATION IS AVAILABLE. KC-RUMI-30 KOH-EFFICIENT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 19960424 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 3/5. IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, WHEN THE RUMI KOH-EFFICIENT WAS PLACED INTO THE VAGINA, IT CAUSED MAJOR VAGINAL LACERATIONS. DOCTOR IS CONCERNED THAT THE CUP IS DEFECTIVE. DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00036 KC-RUMI-30 KOH-EFFICIENT 2024-08-0000013.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929088 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 2/5. IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, WHEN THE RUMI KOH-EFFICIENT WAS PLACED INTO THE VAGINA, IT CAUSED MAJOR VAGINAL LACERATIONS. DOCTOR IS CONCERNED THAT THE CUP IS DEFECTIVE. DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00035 KC-RUMI-30 KOH-EFFICIENT 2024-08-0000012.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929087 ↗
• InjuryFeb 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FRAGMENT OF KOH CUP RESIN WAS FOUND IN THE ABDOMINAL CAVITY WHILE CLEANING IN TLH TREATMENT. THE DOCTOR ASKS WHAT WILL HAPPEN IF THE FRAGMENTS OF RESIN ARE NOT COLLECTED. IT IS REPORTABLE IN JAPAN. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00004 KC-RUMI-30 KOH-EFFICIENT 2024-01-0000404.

  Patient problems: Foreign Body In Patient

  MAUDE report 18717314 ↗
• InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18631014 ↗
• MalfunctionOct 11, 2020Material Rupture

  OCCLUDER BALLOON POPPED. PATIENT INJURY - LACERATION. KOH-EFFICIENT RUMI 3-0CM KC-RUMI-30 (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 10660147 ↗
• MalfunctionOct 12, 2018Leak/Splash

  DOCTOR "TESTED THE "DONUT" OUTSIDE OF THE PATIENT AND IT WAS FINE. BEGAN TO USE IT INSIDE THE PATIENT, AND ONLY ONCE IT WAS FULLY INFLATED DID IT START TO LEAK - SPRINGING OUT LIKE A FOUNTAIN ONTO THE OPERATING ROOM FELLOW." INCREASED LENGTH OF SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960659 ↗