MAUDE Adverse Event Report: COOPERSURGICAL, INC COOPERSURGICAL, INC; UTERINE MANIPULATOR

Model Number MANIPULATOR UT 5.1MM RUMI 6CM

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/21/2014

Event Type  Other  

Event Description

Balloon burst.A portion of balloon came in contact with the pelvic cavity, but was retrieved.

• Brand Name: COOPERSURGICAL, INC
• Type of Device: UTERINE MANIPULATOR
• Manufacturer (Section D): COOPERSURGICAL, INC; 75 corporate dr; trumbull CT 06611
• MDR Report Key: 4068395
• MDR Text Key: 4815678
• Report Number: MW5038086
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MANIPULATOR UT 5.1MM RUMI 6CM
• Device Catalogue Number: UML516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR