RUMI II Koh-EfficientRecalls & reported problems across all models
Coopersurgical, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 5 models of RUMI II Koh-Efficient by Coopersurgical, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2018 and Jun 12, 2026 — classified as 7 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RUMI II Koh-Efficient problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Detachment of Device or Device Component4
- Break2
- Defective Component1
- Difficult or Delayed Separation1
- Fracture1
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Laceration(s)6
- Insufficient Information5
- No Known Impact Or Consequence To Patient2
- Abnormal Vaginal Discharge1
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
RUMI II Koh-Efficient models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RUMI II Koh-Efficient KC-RUMI-30Culdoscope (And Accessories)12 reports
- RUMI II Koh-Efficient KC-RUMI-35Culdoscope (And Accessories)8 reports
- RUMI II Koh-Efficient KC-RUMI-25Culdoscope (And Accessories)1 report
- RUMI II Koh-Efficient KCS-RUMI-30Culdoscope (And Accessories)1 report
- RUMI II Koh-Efficient KCS-RUMI-35Culdoscope (And Accessories)1 report
Recent RUMI II Koh-Efficient adverse event reports
The 15 most recent reports across all models, 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 ↗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 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 ↗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 ↗MalfunctionAug 8, 2024
THE SURGEON ASSEMBLED THE MANIPULATOR PRIOR TO INSERTION, AND INSPECTED IT AGAIN ON REMOVAL AND NOTED THAT THE CUP WAS NOT ATTACHED. MANUFACTURER RESPONSE FOR CULDOSCOPE (AND ACCESSORIES), RUMI II KOH-EFFICIENT (PER SITE REPORTER). THEY HAVE OPENED AN INVESTIGATION AND ARE WORKING WITH THE HOSPITAL TO COMPLETE THEIR INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 19937665 ↗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 ↗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 ↗MalfunctionApr 30, 2024Fracture; Fracture
PATIENT UNDERWENT LAPAROSCOPIC ACESSA ULTRASOUND GUIDED RADIOFREQUENCY FIBROID ABLATION, DIAGNOSTIC HYSTEROSCOPY, HYSTEROSCOPIC MYOMECTOMY, DIAGNOSTIC LAPAROSCOPY ON (B)(6) 2024. NO ISSUES AT TIME OF PROCEDURE. FOLLOW UP APPOINTMENT DUE TO INCREASED VAGINAL DISCHARGE. HARD PLASTIC BLUE OBJECT WEDGED DEEP IN VAGINA OVER CERVIX. FOREIGN BODY REMOVED BY PROVIDER MANUALLY WITH TWO-DIGIT EXAM. INSPECTED AND NOTED TO BE THE CERVICAL CAGE PORTION OF THE RUMI MANIPULATOR THAT WAS USED FOR ACESSA SURGERY. THE DISTAL PORTION OF THE RING OF THE MANIPULATOR APPEARED TO HAVE SNAPPED OFF OF THE REST OF THE RING DEVICE. NO INJURY TO PATIENT. KC-RUMI-25 KOH-EFFICIENT (B)(4).
Patient problems: Abnormal Vaginal Discharge
MAUDE report 19215913 ↗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 ↗
Other Coopersurgical, Inc. products
All Coopersurgical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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