MAUDE Adverse Event Report: ELEKTA LIMITED ADVANCED GYNECOLOGICAL APPLICATOR VENEZIA; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Lot Number 1000083191

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2020

Event Type  malfunction  

Event Description

The patient finished 5 high dose rate brachytherapy.Upon removal of the venezia brachytherapy applicator, the lunar ovoid broke at the "click mechanism" after being removed from the patient.

• Brand Name: ADVANCED GYNECOLOGICAL APPLICATOR VENEZIA
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): ELEKTA LIMITED; 400 perimeter center terrance ne suite 50; atlanta GA 30346
• MDR Report Key: 10689399
• MDR Text Key: 211691485
• Report Number: 10689399
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1000083191
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA