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

Model Number 60-6085-201A

Device Problems Deflation Problem (1149); Inflation Problem (1310); Defective Device (2588)

Patient Problem Uterine Perforation (2121)

Event Date 12/26/2022

Event Type  malfunction  

Event Description

Vcare medium was found to have a defective balloon.It was difficult to inflate and deflate and may have helped contribute to the uterine perforation that occurred during the hysterectomy procedure.Vcare was removed from service and replaced with a working one.No additional care or monitoring required as the uterus was removed as planned during the hysterectomy procedure.No other injury to other structures noted.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16494774
• MDR Text Key: 310788803
• Report Number: 16494774
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

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 Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202202281
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female