MAUDE Adverse Event Report: CONMED CONMED UTERINE MANIPULATOR

Model Number 60-6085-201

Device Problems Inflation Problem (1310); Leak/Splash (1354); Device Slipped (1584)

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

Event Date 06/16/2016

Event Type  malfunction  

Event Description

Uterine manipulator inserted into uterus, it was noted that it slipped out upon inspection by physician the balloon would not hold when inflated due to leakage.Device to be given to the conmed rep.

• Brand Name: CONMED UTERINE MANIPULATOR
• Type of Device: UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED; utica NY 13502
• MDR Report Key: 5754463
• MDR Text Key: 48444650
• Report Number: MW5063061
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-6085-201
• Device Lot Number: 201602151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR