MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI - SYSTEM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number UML516

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

The rumi system - uterine manipulator tip bent during procedure.Removed from pt.

• Brand Name: RUMI - SYSTEM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 16304545
• MDR Text Key: 308958026
• Report Number: MW5114687
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UML516
• Device Lot Number: 325231
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White