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

Device Problems Break (1069); Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 06/03/2020

Event Type  Injury  

Event Description

There was a blue plastic piece to the rumi while performing uterus manipulation during a robotic hysterectomy.The plastic piece broke and caused all of the metal pieces to disperse and break off and fall apart.(the plastic piece holds all of these pieces together).The tip was stuck on the disposable rumi piece and we couldn't locate all the pieces to ensure there wasn't an rfo.Fda safety report id# (b)(4).

• Brand Name: RUMI UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 10223756
• MDR Text Key: 197577260
• Report Number: MW5095327
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention