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

Catalog Number UMW676

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 06/06/2018

Event Type  Injury  

Event Description

The rumi manipulator plastic tip broke and metal poked through damaging the sigmoid colon in three areas requiring surgical intervention to repair the injury also resulting in prolonged admission.

• Brand Name: RUMI TIP
• Type of Device: CANNULA MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT 06611
• MDR Report Key: 7605293
• MDR Text Key: 111424678
• Report Number: MW5077882
• Device Sequence Number: 0
• 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: Physician
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UMW676
• Device Lot Number: 231791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR