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

Model Number UMG670

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 04/28/2017

Event Type  malfunction  

Event Description

Uterine manipulator would not connect to system.A new device was opened and worked as expected.Manufacturer response for disposable uterine manipulator tip, the rumi system (per site reporter): manufacturer provided rga# for product return evaluation.

• Brand Name: RUMI SYSTEM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• MDR Report Key: 6568619
• MDR Text Key: 75257140
• Report Number: 6568619
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/13/2019
• Device Model Number: UMG670
• Device Catalogue Number: UMG670
• Device Lot Number: 213975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 78