MAUDE Adverse Event Report: CONMED CORPORATION V-CARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

Uterine manipulator came about into 3 sections when in use inside the patient.Fda safety report id # (b)(4).

• Brand Name: V-CARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 11706230
• MDR Text Key: 247130827
• Report Number: MW5100934
• Device Sequence Number: 1
• Product Code: LKF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2021
• 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: 37 YR
• Patient Weight: 86