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

Model Number 60-6085-201A

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  malfunction  

Event Description

Vcare balloon broke upon insertion.Another vcare had to be opened.Manufacturer response for vcare medium, vcare medium (per site reporter).Provided replacement supply.

Event Description

Vcare balloon broke upon insertion.Another vcare had to be opened.Manufacturer response for vcare medium, vcare medium (per site reporter).Provided replacement supply.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 12165573
• MDR Text Key: 261472439
• Report Number: 12165573
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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 Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202103151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1