MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT

Model Number	AD750-KE35
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
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 during a robotic assisted laparoscopic hysterectomy, the patient experienced a vaginal laceration.In addition to the delineator, the ally ii ups was being utilized during the procedure.Laceration was sutured, vaginal packing was placed and the patient was stable.Ad750-ke35 koh-eff 2025-10-0000457.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h11.Distribution history a distribution history record review was not possible for this product as the lot number was not provided for investigation manufacturing record review: a dhr review was not possible as a lot number was not provided.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions where laceration was involved with this product.Product receipt the complaint product has not been returned to coopersurgical.Visual eval.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional eval.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 there was no relevant customer or clinical information provided.Root cause no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation, nor information such as the lot number was provided.
Event or Problem Description
No additional information.

• Brand Name: ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 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: 23522118
• Report Number: 1216677-2025-00048
• Device Sequence Number: 18611170
• Product Code: HEW
• UDI-Device Identifier: 00888937012750
• UDI-Public: (01)00888937012750
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female