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

Model Number	KCS-RUMI-35
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon assembled the manipulator prior to insertion, and inspected it again on removal and noted that the cup was not attached.Manufacturer response for culdoscope (and accessories), rumi ii koh-efficient (per site reporter).They have opened an investigation and are working with the hospital to complete their investigation.

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• MDR Report Key: 19937665
• Report Number: 19937665
• Device Sequence Number: 7414352
• Product Code: HEW
• UDI-Device Identifier: 00888937015126
• UDI-Public: (01)00888937015126
• 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): 03/04/2024
• Report Date (Section F): 03/06/2024

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: KCS-RUMI-35
• Device Catalogue Number: KCS-RUMI-35
• Device Lot Number: 341624
• 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: 08/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Date Report Sent to FDA: 03/06/2024