MAUDE Adverse Event Report: Coopersurgical, Inc. Advincula Delineator Uterine Manipulator; Culdoscope (And Accessories)

Model Number	AD750SC-KE30
Medical Device Problem Codes	Material Rupture (1546); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Advincula delineator uterine manipulator balloon ruptured and deflated while it was inside patient's vaginal cavity.The surgeon was working on robot console.He scrubbed in to remove the manipulator, and a new manipulator was inserted.

• Brand Name: Advincula Delineator Uterine Manipulator
• Common Device Name: Culdoscope (And Accessories)
• Manufacturer (Section D): Coopersurgical, Inc.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 50927401
• Report Number: 50927401
• Device Sequence Number: 15829906
• Product Code: HEW
• UDI-Device Identifier: 00888937021356
• UDI-Public: (01)00888937021356
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 09/05/2026
• Report Date (Section F): 09/05/2026

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: AD750SC-KE30
• Device Lot Number: 550034044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• 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 Sex: Female
• Date Report Sent to FDA: 09/05/2026