MAUDE Adverse Event Report: COOPER SURGICAL RUMI ADVANCED UTERINE MANIPULATION SYSTEM; RUMI MANIPULATOR

Catalog Number KCS-RUMI-40

Device Problems Detachment Of Device Component (1104); Unknown (for use when the device problem is not known) (2204); Device, removal of (non-implant) (2608)

Patient Problems Fever (1858); Joint Swelling (2356); Foreign body, removal of (2365)

Event Date 04/29/2014

Event Type  Injury  

Event Description

On monday, (b)(6) 2015, tgh operating room director became aware that a patient who had undergone surgery at tgh on (b)(6) 2014 had retained a foreign body related to equipment used in the procedure.The procedure performed was robotic-assisted left salpingo-oophorectomy, lysis of adhesions and cystoscopy.The physician had advised that a piece (robust koh cup) of device #1 had been retained during the procedure.The patient returned to the tgh operating room around 1700 on (b)(6) 2015 for the removal of the retained foreign object.It was the end of a cooper medical disposable rumi manipulator.When evaluating another cooper medical disposable rumi manipulator the retained foreign object piece is connected in a manner that does not allow it to be disconnected.The removed retained foreign object device has been placed into evidence.Mfr ref #: 1216677-2015-00009.

• Brand Name: RUMI ADVANCED UTERINE MANIPULATION SYSTEM
• Type of Device: RUMI MANIPULATOR
• Manufacturer (Section D): COOPER SURGICAL; trumbull CT 06611
• MDR Report Key: 4758444
• MDR Text Key: 5785518
• Report Number: 4758444
• Device Sequence Number: 1
• Product Code: LKF
• 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: 03/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCS-RUMI-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR