MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; RUMI II KOH-EFFICIENT- 3.0 CM FOR USE WITH THE RUMI II HANDLE

Model Number	KC-RUMI-30
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	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component is being returned.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
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).
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi on 03apr2025.Manufacturing record review: dhr was reviewed and no non-conformities related to the complaint condition were noted.Historical complaint review: a review of the 2-year complaint history did show similar reported complaint condition.Product receipt: the complaint unit was returned 18feb2026.Visual evaluation: the returned product consisted of only the cup.On the cup, it was confirmed that glue was applied during manufacture of the device.The rest of the device was not returned for full evaluation.Functional evaluation: functional evaluation of the component was not possible as only a portion of the device was returned for evaluation.Root cause: based on the information provided in the complaint, a definitive root cause for the reported issue could not be conclusively determined at this time.Evaluation of the returned device found that the cup was detached from the main body of the kc; however, visual inspection and device history record (dhr) review indicate the product was manufactured in accordance with specifications.Inventory stock from lot 550023882 was reviewed for availability to support further investigation, but no units were found.One potential contributing factor may be improper handling of the product.To mitigate the risk of cup detachment, csi stafford performs 100% in process inspection using a bend test, followed by aql quality control inspection requiring units to pass bend and pull testing.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- 3.0 CM FOR USE WITH THE RUMI II HANDLE
• 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: 24365185
• Report Number: 1216677-2026-00010
• Device Sequence Number: 21247860
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: (01)00888937015072(10)550023882
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 550023882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female