MAUDE Adverse Event Report: COOPERSURGICAL RUMI II

Model Number RUMI II 35

Device Problems Component Falling (1105); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Event Description

A couple of very small pieces of the blue coating on the rumi cup were found to have come off the device and were in the patient's abdomen during a robotic assisted total laparoscopic hysterectomy.The pieces were retrieved and the device removed from the patient.No adverse effects were noted and the patient was discharged home later that day.

• Brand Name: RUMI II
• Type of Device: RUMI
• Manufacturer (Section D): COOPERSURGICAL; trumbull CT 00611
• MDR Report Key: 7525415
• MDR Text Key: 108738690
• Report Number: MW5077295
• Device Sequence Number: 0
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: RUMI II 35
• Device Catalogue Number: REF KC-UMI 35
• Device Lot Number: 243276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR