MAUDE Adverse Event Report: CONMED VCARE; SMALL UTERINE MANIPULATOR

Model Number 60-6085-200

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

Diagnosis or reason for use: laparoscopic robotic total hysterectomy.Conmed vcare small uterine manipulator came apart while being removed from the patient.All parts accounted for and visualized at the time of occurence.Device sequestered.

• Brand Name: VCARE
• Type of Device: SMALL UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED; utica NY 13502
• MDR Report Key: 4217307
• MDR Text Key: 17993294
• Report Number: MW5038892
• 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: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 60-6085-200
• Device Catalogue Number: 60-6085-200
• Device Lot Number: 130930 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR