MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; RUMI II KOH-EFFICIENT- 3.5 CM

Model Number	KC-RUMI-35
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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).
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h11 distribution history a distribution history record review was not possible for this product as the product type nor a lot number was provided for investigation.Manufacturing record review a dhr review was not possible as a lot number was not provided.Historical complaint review a review of the 2-year complaint history did show similar reported complaint condition.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, complaint will be confirmed based on the pictures provided in the complaint file.Functional evaluation evaluation of the complaint product could not be completed as the complaint product was not been returned to coopersurgical.However, the complaint condition is similar to other complaints as mentioned earlier.Root cause no definitive root cause for this issue could be reliably determined at this time, with the information provided in the complaint.Complaint product was not returned for investigation.To mitigate cup detachment, csi stafford has implemented 100% in process inspection of the product via bend test, followed by an aql qc inspection requiring the units also pass bend/pull test.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.
Event or Problem Description
No additional information.

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: RUMI II KOH-EFFICIENT- 3.5 CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 24454086
• Report Number: 1216677-2026-00011
• Device Sequence Number: 10148519
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: (01)00888937015089
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K954311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female