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

Model Number	ZSI1151
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that theuterine manipulator was being used during a laparoscopic bilateral salpingo-oophorectomy (lbso), it was unknown at the time that the tip of the device had broken off into the patient.The patient called the ob clinic 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.Attempts have been made, but no additional information has been provided.1216677-2026-00006 zsi1151 zumi (b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h10, h11.Distribution history: this rumi uterine manipulator 4.5mm is processed at the trumbull, ct, facility.Manufacturing record review: a review of the device history record could not be located due to lack of lot information.However, it should be noted at the time of processing, records from each lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition in late 2024, but the complaint was not confirmed.Product receipt: the complaint unit was not returned.Visual evaluation: visual examination of the complaint is not possible as it was not returned.The product is designed to be disposable.Functional evaluation: a functional evaluation is not possible as the product was not returned.The product is designed to be disposable.Root cause: a root cause is not readily available.An image provided confirms the tip had broken off.Based on the length, it would appear it had been exposed to force and snapped off at the cervical stop.This would indicate the force applied had occurred during the end of the procedure as the complaint did not indicate an incomplete procedure.The complaint is considered confirmed due to the submission of the image.However, with no other information on the how the unit was handled in the procedure no definitive root cause could be determined.A review of the risk assessment captures the possibility of a foreign body in patient with a s3 and o1 (9, 1) under the mechanical hazards section.This designation has the risk in the low or green zone.In review of the ifu, the instruction for use specifically directs users to ensure the device is intact after use and removal to avoid parts do not remain in the vaginal canal.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.

• Brand Name: ZUMI
• Common Device Name: ZUMI UTERINE MANIPULATOR
• 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: 24246228
• Report Number: 1216677-2026-00006
• Device Sequence Number: 8326497
• Product Code: LKF
• UDI-Device Identifier: 00888937013221
• UDI-Public: (01)00888937013221
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K941458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: ZSI1151
• Device Catalogue Number: ZSI1151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White