MAUDE Adverse Event Report: COOPERSURGICAL, INC. THE RUMI SYSTEM; UTERINE MANIPULATOR TIP L 5.1MMX6CM

Model Number	UML516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: foreign: japan.Device is in the process of 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 ovarian cystectomy, a tip perforated the uterus by approximately 2 cm, although the uterine length was measured by a sonde beforehand.During the procedure, the manipulator was held by a nurse.It is highly likely that the perforation occurred while the manipulator was in an anteflexed position rather than during a pushing motion.The doctor realized the perforation after using the manipulator.Requests for additional information were made, but no further information was provided.Uml516 rumi (b)(4).
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi in august 2024.Manufacturing record review: dhr-550013680 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.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint product was returned on 12/9/25.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: the important tip length dimension, 2.35 ±.05 inches, part number 53016 assembly drawing, measured 2.339 inches which is within specification.Any relevent customer or clinical information: the following clinical information was provided by coopersurgical medical.Lactation: based on available evidence, lactation is associated with an increased risk of uterine perforation during intrauterine procedures, and although direct data for uterine manipulators are lacking, it is reasonable to infer that this risk may also apply to their use in lactating patients.Earlier postpartum patients are at the highest risk, in the literature, for perforation during uterine procedures.Anteflexed: an anteflexed or retroflexed uterus can increase the risk during manipulator placement.Other potential root causes considered are technique factors: application of excessive force, inadequate visualization during manipulator adjustments, inaccuracy of uterine measurement prior to placement of the manipulator, operator experience.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information.

• Brand Name: THE RUMI SYSTEM
• Common Device Name: UTERINE MANIPULATOR TIP L 5.1MMX6CM
• 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: 23789027
• Report Number: 1216677-2025-00055
• Device Sequence Number: 17570902
• Product Code: LKF
• UDI-Device Identifier: 00888937001426
• UDI-Public: (01)00888937001426(10)550013680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K932115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UML516
• Device Catalogue Number: UML516
• Device Lot Number: 550013680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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