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

Model Number 60-6085-201A

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient was undergoing robotic assisted total laparoscopic hysterectomy.Uterine manipulator in place.The handle broke.Manipulator was then taken out.

• Brand Name: CONMED VCARE MEDIUM UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY
• MDR Report Key: 17288535
• MDR Text Key: 318764863
• Report Number: MW5119236
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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: 2797
• Device Lot Number: 202303271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female