MAUDE Adverse Event Report: CONMED CORP. VCARE SMALL UTERINE MANIPULATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number 60-6085-200A

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2021

Event Type  malfunction  

Event Description

Vcare balloon and green cup separated from the uterine manipulator while in the patient.This device should have remained intact.Surgeon retrieved the two separated items through the vagina using a grasper.Fda safety report id# (b)(4).

• Brand Name: VCARE SMALL UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORP.
• MDR Report Key: 11812070
• MDR Text Key: 250437367
• Report Number: MW5101300
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/10/2021

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 Expiration Date: 11/30/2022
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202011301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2021
• 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: 68 YR