MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA DELINEATOR UTERINE MANIPULATOR; CULDOSCOPE (AND ACCESSORIES)

Model Number	AD750SC-KE40
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon from advincula delineator was removed from the manipulator and left in the patient.Recommend that the balloon (pneumo occluder) not be a detachable item.

• 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: 17331938
• Report Number: 17331938
• Device Sequence Number: 7331582
• Product Code: HEW
• UDI-Device Identifier: 00888937021370
• UDI-Public: (01)00888937021370(10)305275(17)240510
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/02/2023
• Report Date (Section F): 05/02/2023

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-KE40
• Device Catalogue Number: AD750SC-KE40
• Device Lot Number: 305275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2023
• 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: 05/02/2023