MAUDE Adverse Event Report: COOPER SURGICAL INC. RUMI II HANDLE; MANIPULATOR/INJECTOR UTERINE

Catalog Number KCS-RUMI-30

Device Problem Break (1069)

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

Event Date 12/21/2016

Event Type  malfunction  

Event Description

After rumi handle 3.0 was placed in cervix, the device fell into two pieces.All items accounted for and new device was placed.

• Brand Name: RUMI II HANDLE
• Type of Device: MANIPULATOR/INJECTOR UTERINE
• Manufacturer (Section D): COOPER SURGICAL INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 6228287
• MDR Text Key: 64145215
• Report Number: MW5067074
• Device Sequence Number: 1
• Product Code: LKF
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: KCS-RUMI-30
• Device Lot Number: 200800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR