MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.0 CM ULTEM KOH-EFFICIENT

Model Number	AD750-KE30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: march 2025.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 the patient underwent a robotic-assisted total laparoscopic hysterectomy with bilateral salpingo-oophorectomy in (b)(6) 2025.During the procedure, the uterine manipulator came out and was replaced with a different brand of uterine manipulator.After being replaced, the second manipulator still did not hold.The uterine manipulator manufacturer was called during the case to help troubleshoot.When reinserting the manipulator, the uterus was perforated with the tip of the manipulator.Difficult uterine manipulation caused urine to have red tinge.Doctor was called to do a cystoscopy after vaginal cuff was closed.Both ureters were open.User claims that the device failed, but the nature of the failure was not specified.Attempts were made, but no additional information is available.Ad750-ke30 uterine manipulator (b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured on 9/10/2024.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history did not show similar complaint conditions where the manipulator came out.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Any relevant customer or clinical information uterine manipulator was replaced with a different brand of uterine manipulator during procedure.Root cause: the root cause of this issue cannot be reliably determined based on the information provided.The product was not available for root cause analysis.A possible root cause could be due to improper handling of the device.The ad750-ke30 is also not validated to be used with other brands of uterine manipulators as stated in the complaint condition.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.0 CM ULTEM KOH-EFFICIENT
• 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: 21890686
• Report Number: 1216677-2025-00015
• Device Sequence Number: 8115779
• Product Code: HEW
• UDI-Device Identifier: 00888937012743
• UDI-Public: (01)00888937012743(10)550014633
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143650
• 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): 06/23/2025

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: AD750-KE30
• Device Catalogue Number: AD750-KE30
• Device Lot Number: 550014633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Race: White