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

Catalog 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 patient.

• Brand Name: THE RUMI SYSTEM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPER SURGICAL COOPERSURGICAL, INC.; trumbull CT 06611
• MDR Report Key: 15977555
• MDR Text Key: 305586493
• Report Number: MW5113766
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue 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: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White