MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; CULDOSCOPE (AND ACCESSORIES)

Model Number	KC-RUMI-35
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent a laparoscopic unilateral salpingo-oophorectomy.The case was uncomplicated and she went home the same day.She cancelled her postop visit and her ob/gyn saw her last week.At that time, she was found to have a portion of the uterine manipulator retained in the vagina.

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 19654922
• Report Number: 19654922
• Device Sequence Number: 12411139
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 00888937015089
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/22/2024
• Report Date (Section F): 02/22/2024

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: KC-RUMI-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• 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
• Patient Age: 37 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/22/2024