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

Model Number	KC-RUMI-35
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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).
Additional Manufacturer Narrative
Device was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: KOH-EFFICIENT,RUMI
• 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: 24802579
• Report Number: 1216677-2026-00027
• Device Sequence Number: 10707567
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: (01)00888937015072(10)550023890
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 550023890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/09/2026
• 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