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

Model Number 60-6085-201A

Device Problem Gas/Air Leak (2946)

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

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Upon initial attempt to inflate balloon according to manufacturer¿s recommendations, our conmed corporation, vcare, medium, vaginal-cervical-ahluwalia¿s-retractor-elevator, balloon was leaking.The balloon would not hold the air being introduced, so the device had to be exchanged.

• Brand Name: VCARE MEDIUM UTERINE MANIPULATOR
• Type of Device: CANNULA MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 8388043
• MDR Text Key: 137943547
• Report Number: MW5084599
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• 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: 201812171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR