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

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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number: 550031609 or 550032580 device was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
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.

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: COLPOTOMY TUBE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 -135
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611--135 ; 4752651582
• MDR Report Key: 25488407
• Report Number: 1216677-2026-00048
• Device Sequence Number: 9716626
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: (01)00888937015089(10)550031609
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 550031609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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