MAUDE Adverse Event Report: COOPER SURGICAL, INC. RUMI 6CM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number UMW676

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911); Physical Resistance/Sticking (4012)

Patient Problem Rupture (2208)

Event Date 03/17/2020

Event Type  Injury  

Event Description

Patient admitted for robotic laparoscopic fulguration with excision of lesion.A small tip rumi was placed in the uterus.At a specific point in the procedure, the surgeon instructed the surgical tech to instill methylene blue into the dye port on the rumi.Robotic surgeries are often done in the dark and the cooper surgical rumi ports have no differentiation.They look exactly the same with universal connectivity which caused the tech to choose the wrong port.She tried to instill the dye and when she met resistance, she escalated to the surgeon.The surgeon instructed her to try again.She met resistance a second time after which the assistant surgeon entered the surgical arena.He attempted to instill the dye and it went into the uterine balloon causing it to rupture the uterus.A 3cm rent was notice after deflating the rumi.It was noted at the time and subsequent to the procedure that the two ports do not differentiate in color or connectivity which lends itself to confusion during the procedure.Fda safety report id# (b)(4).

• Brand Name: RUMI 6CM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPER SURGICAL, INC.; trumball CT 06611
• MDR Report Key: 10194747
• MDR Text Key: 196769845
• Report Number: MW5095205
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UMW676
• 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 Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 65