MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB VENEZIA; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number 126125

Patient Problem Insufficient Information (4580)

Event Date 06/06/2023

Event Type  malfunction  

Event Description

Patient being treated for a brachytherapy implant utilizing the venezia applicator.Patient was planned and treated and upon removal of the applicator following treatment the tandem stem of the applicator broke outside of the patient.

• Brand Name: VENEZIA
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; 400 perimeter center terrace,; suite 50; atlanta GA 30346
• MDR Report Key: 17623019
• MDR Text Key: 321940690
• Report Number: 17623019
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 126125
• Device Lot Number: 1000098084
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA