MAUDE Adverse Event Report: CONMED CORP VCARE

Model Number REF 60-6085-200

Device Problems Hole In Material (1293); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

Procedure: total laparoscopic hysterectomy with bilateral salpingectomy and conversion of the bilateral ovaries.Physician: (b)(6).Issue: the vcare balloon would not stay inflated a hole was suspected and a new instrument was opened and used without incident.No pt harm was noted.

• Brand Name: VCARE
• Type of Device: VCARE
• Manufacturer (Section D): CONMED CORP; utica NY 13502
• MDR Report Key: 3629179
• MDR Text Key: 20328052
• Report Number: MW5034485
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: REF 60-6085-200
• Device Catalogue Number: 14390
• Device Lot Number: 1305131
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR