MAUDE Adverse Event Report: COOPERSURGICAL, INC. ZUMI; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	ZSI1151
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Uterine manipulator was being used during an lbso [laparoscopic bilateral salpingo-oophorectomy], it was unknown at the time that the tip of the device had broken off into the patient.The patient called the ob clinic on [redacted] informing them something had been expelled from her vagina, of which appears to be the tip (2inch) of the zumi, where the cuff is inflated upon insertion into the cervix.

• Brand Name: ZUMI
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 24002645
• Report Number: 24002645
• Device Sequence Number: 10509439
• Product Code: LKF
• UDI-Device Identifier: 00888937013221
• UDI-Public: (01)00888937013221
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/24/2025
• Report Date (Section F): 12/24/2025

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: ZSI1151
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/24/2025