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

Model Number 60-6085-200

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Manipulator uterine vcare retractor small 60-6085-200: upon removal of the small v-care from the vagina, it was noted that both the balloon and the green cup came off.Fda safety report id # (b)(4).

• Brand Name: MANIPULATOR UTERINE VCARE RETRAC
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 12108382
• MDR Text Key: 260147586
• Report Number: MW5102269
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2021

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: 60-6085-200
• Device Catalogue Number: 60-6085-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• 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: 74 YR