MAUDE Adverse Event Report: COOPERSURGICAL, INC. ALLY UTERINE POSITIONING SYSTEM; UTERINE MANIPULATOR

Model Number	AU-UPS
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Uterine Perforation (2121); Bowel Perforation (2668)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is being returned for investigtion.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was scheduled to have a total laparoscopic hysterectomy on (b)(6), 2025.During the procedure, the patient experienced a rectal injury and a left ureteral injury.She was then converted to an exploratory laparotomy and an open hysterectomy/oophorectomy were completed.Patient underwent a diverting loop ileostomy, rigid proctoscope with left ureteral.Patient was admitted to the hospital.Customer reported that the unit's arm cable wire was fraying and was subsequently replaced after the incident.1216677-2025-00035 au-ups ally 2025-06-0000238.
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h7, h8, h11 distribution history: this complaint unit was manufactured at csi on 11/06/2022.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Isolated incident.Product receipt: the complaint unit was returned 6/10/2025.Visual evaluation: visual examination of the complaint unit revealed the internal cable had signs of fraying.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the unit was not able to keep the gooseneck in its rigid state.Any relevant customer or clinical information: the customer conveyed the procedure had to be converted from one intended hysterectomy to an additional procedure to address rectal and ureteral injuries.Root cause: a worn cable will impact the cable tension exerted when pulled back.Full tension is required to produce the rigid state on the gooseneck.Partial loss of tension will result in a downward drooping motion from the weight on the tip end.Rate of drooping would depend on the weight/mass at the tip.It is designed to support weight without movement and each unit is tested with a 2.0 kg weight on the tip.The drooping on this unit would be observable, slow and stop when reaching a bottom.Any static force exerted on that surface would be the weight of 1 to 3 links, the tip, the attached device and possibly excised biological material.There is no correlation with a loose end drooping to a static stop and the complaint description which suggests more than a static force was involved.The unit was evaluated, repaired with a new cable, tested to specifications and returned to the customer.The device is under warranty for 1 year and serviceable afterwards.As the device was repaired 3 years after its sale no additional actions are required at this time.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information.

• Brand Name: ALLY UTERINE POSITIONING SYSTEM
• Common Device Name: 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: 22371535
• Report Number: 1216677-2025-00035
• Device Sequence Number: 7918751
• Product Code: LKF
• UDI-Device Identifier: 00888937015836
• UDI-Public: (01)00888937015836
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: AU-UPS
• Device Catalogue Number: AU-UPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female