MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number 60-6085-201

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2016

Event Type  Injury  

Event Description

The balloon on vcare uterine manipulator would not remain inflated inside or outside the uterus, rendering it unusable for the case.New one opened.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 5466284
• MDR Text Key: 39225495
• Report Number: 5466284
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/05/2017
• Device Model Number: 60-6085-201
• Device Lot Number: 201511161
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR