RUMI II Koh-Efficient KC-RUMI-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888937015089), received between Jan 6, 2021 and Jun 12, 2026 — classified as 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE, THE KOH CUP BECAME DETACHED WHEN REMOVING THE MANIPULATOR FROM THE PATIENT. THE CUP REMAINED SEATED AROUND THE CERVIX AS THE REST OF THE ASSEMBLED MANIPULATOR WAS REMOVED. THE PROVIDER WAS ABLE TO GRASP THE CUP WITH ANOTHER INSTRUMENT AND REMOVE IT EASILY, CAUSING NO HARM TO THE PATIENT. DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. 1216677-2026-00048 KC-RUMI-35 KOH-EFFICIENT 2026-05-0000330

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488407 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY. PROVIDER WAS USING RUMI KOH EFFICIENT DURING CASE AND DID NOT GET GOOD MANIPULATION. WHEN SHE WENT TO CHECK THE VAGINA AFTER THE PROCEDURE, SHE FOUND THE RUMI KOH CUP INSIDE OF THE PATIENT AND WAS THANKFUL SHE HAD THOUGHT TO CHECK AS IT IS NOT NORMAL PRACTICE. CUP WAS FULLY DETACHED FROM KOH EFFICIENT AND AROUND CERVIX. THE PATIENT IS OKAY AS IT WAS REMOVED PRIOR TO LEAVING OR. AS A RESULT THEY WILL NOW COUNT CUPS AND TIPS EACH CASE. KC-RUMI-35 KOH-EFFICIENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454086 ↗
• MalfunctionJul 2, 2024

  PATIENT UNDERWENT A LAPAROSCOPIC UNILATERAL SALPINGO-OOPHORECTOMY. THE CASE WAS UNCOMPLICATED AND SHE WENT HOME THE SAME DAY. SHE CANCELLED HER POSTOP VISIT AND HER OB/GYN SAW HER LAST WEEK. AT THAT TIME, SHE WAS FOUND TO HAVE A PORTION OF THE UTERINE MANIPULATOR RETAINED IN THE VAGINA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19654922 ↗
• MalfunctionSep 26, 2022Defective Component; Material Integrity Problem; Defective Component; Material Integrity Problem

  RUMI INSTRUMENT USED DURING HYSTERECTOMY FOR UTERINE MANIPULATION WAS MELTED WITH HARMONIC IN PROCESS. SMALL FLAKES FROM END OF RUMI FOUND FLOATING IN SPECIMEN CONTAINER AND SOME PIECES OF RUMI WERE REMOVED FROM PATIENT DURING CASE BY DOCTOR. KOH-EFFICIENT RUMI 3.5CM E-COMPLAINT: (B)(4), MW REPORT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485496 ↗
• MalfunctionJun 16, 2021Use of Device Problem

  REPORT SUBMITTED BY CSI (B)(4) ON BEHALF OF END-USER- DOCTOR (B)(6) (REPORT FROM (B)(6)). INCIDENT DETAIL - "VAGINAL LACERATION WAS OCCURRED DURING USE OF KOH-EFFICIENT 4.0CM." PATIENT INJURED. REPORTABLE BASED ON JAPANESE REGULATION. MEDICAL INTERVENTION -HEMOSTATIC SUTURE ON CORRESPONDED WOUND. ADDITIONAL INFO STATED "THE INCIDENT MIGHT BE CAUSED BY MISREADING THE SCALE OF KC SIZER. THEREFORE, THE DOCTOR CHOSE WRONG (BIGGER) SIZE OF KOH-EFFICIENT. " KOH-EFFICIENT RUMII 4-0CM KC-RUMI-40. E-COMPLAINT- (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 12009544 ↗
• MalfunctionMay 10, 2021Material Deformation

  DURING ASSEMBLY OF THE 4.0 CUP AND HANDHELD DR SAID KOH CUP CRUMBLED AND COULD NOT BE USED. KOH-EFFICIENT RUMI 4 CM KC-RUMI-40 E-COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11796927 ↗
• MalfunctionJan 25, 2021Mechanical Problem

  E-COMPLAINT-(B)(4). ADDITIONAL REPORT IN REF. TO E-COMPLAINT-(B)(4). REPORT STATED "PRODUCT NOT SLIDING ALONG THE RUMI II HANDLE, TO CLICK INTO PLACE. NOTICED DESIGN WAS DIFFERENT, SO THOUGHT IT WAS A DESIGN FAULT, HOWEVER NEW CUP LOOKED THE SAME AND HAD THE SAME ISSUE WITH NOT GLIDING EASILY. RESULTED IN SURGEON MISSING THE CUP LOCKING INTO POSITION, DEVICE HAD TO BE REMOVED AND TAKEN APART, BEFORE BEING PUT BACK INTO THE PATIENT. ADDITIONAL INFO-ONCE WE HAD THE EQUIPMENT OUT, ITS CLEAR THAT THE NEW DESIGN DOESN'T LOCK IN AS EASILY AND CAN POP OUT OF THE GROOVES. 1216677-2021-00003 KOH-EFFICIENT RUMI 3-5 CM KC-RUMI-35 E-COMPLAINT-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11222539 ↗
• MalfunctionJan 6, 2021Product Quality Problem

  WE HAVE RECENTLY STARTED SEEING THE NEW DESIGN OF KOH-CUP IN THE UK. I HAVE USED THIS TWICE NOW WITH 2 DIFFERENT SURGEONS AND FEEL AS THOUGH THERE ARE A COUPLE ISSUES THAT HAVE COME UP. FIRSTLY, THE CUP IS NOT GLIDING ALONG THE HANDLE AS WELL AS THE OLD DESIGN, AND HAVE FOUND THERE IS NO CLICK WHEN IT GETS INTO PLACE ONCE THE CUP HAS BEEN MOVED INTO POSITION. WITH THE CUP NOT GLIDING AS SMOOTHLY AND NOT HAVING THE WINGS, THIS RESULTS IN SURGEONS SQUEEZING IT SLIGHTLY CAUSING THEM TO MISS THE LOCKING POINT. FINALLY WE HAD AN INCIDENT WHERE THE RUMI HANDLE WAS REMOVED FROM THE PATIENT AND THE CUP AND UTERUS WERE LEFT INSIDE. NOT SURE HOW THE CUP CAME DETACHED. IN MY EYES THIS WAS PRODUCT FAILURE, HOWEVER THE SURGEON DOES NOT FEEL THE NEED TO REPORT IT. KOH-EFFICIENT RUMI 3-5CM KC-RUMI-35 (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11125899 ↗