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

Model Number 60-6085-200A

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

While inflating balloon, liquid was leaking out, so the balloon had hole in it presumably.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 12851459
• MDR Text Key: 281079137
• Report Number: 12851459
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)230315(10)202103151
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202103151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1