MAUDE Adverse Event Report: CONMED VCARE LARGE; RETRACTOR/ELEVATOR

Model Number 60-6085-202

Device Problem Hole In Material (1293)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

Conmed vcare large vaginal-cervical-ahluwalia's retractor elevator had a hole noted in the balloon.Device was unable to be utilized.Reason for use: laparoscopic total hysterectomy, bilateral salpingectomy.

• Brand Name: VCARE LARGE
• Type of Device: RETRACTOR/ELEVATOR
• Manufacturer (Section D): CONMED; utica NY 13502
• MDR Report Key: 3574725
• MDR Text Key: 4076058
• Report Number: MW5033839
• 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: 01/08/2014

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: 10/31/2015
• Device Model Number: 60-6085-202
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 131029 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR