MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; KOH-EFFICIENT,RUMI,3.0CM

Model Number	KC-RUMI-30
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is being returned.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a laparoscopic hysterectomy, the locking mechanism broke on the rumi.The koh cup kept sliding off of the rumi handle.A new koh cup was used and this elevated the problem.Additional time under anesthesia was noted, but no harm to the patient was reported.No additional information is available.Kc-rumi-30, koh-efficient, 2025-11-0000464.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi on 04/10/25.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Historical complaint review: a review of the 2-year complaint history did show similar reported complaint condition, however the complaint was not confirmed.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.If the product should be returned at a later date, any findings will be appended to this investigation.However, the complaint condition will be confirmed based on the image provided.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the unit/product should be returned at a later date, any pertinent findings will be appended to this investigation.Root cause: no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation.With the information provided, a root cause analysis cannot be definitively performed.It is unknown if the user was not able to lock down because the rumi arm was upside down, or other reason.The rumi arm has slots where it allows the rumi arm to lock down when the kc-rumi is slid backwards.However, without the product, a root cause was not possible.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: KOH-EFFICIENT,RUMI,3.0CM
• 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: 23760007
• Report Number: 1216677-2025-00056
• Device Sequence Number: 10075772
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: (01)00888937015072(10)550023899
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 550023899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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
• Patient Sex: Female