MAUDE Adverse Event Report: NUCLETRON FLEXITRON; SYSTEM, APPLICATOR< RADIONUCLIDE, REMOTE_CONTROLLED

Model Number HDR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Underdose (2166)

Event Date 04/03/2015

Event Type  Injury  

Manufacturer Narrative

The user has used the incorrect adaptor.User error.Investigation ongoing.User error; not device related.

Event Description

Patient mistreated with lumencath in combination wtih flexitron.This customer is an old mselectron customer and for mselectron you have to use the adaptor/connector connected to the lumencath when using the x-ray markers.They also used this procedure for flexitron, but for flexitron you should not use the adaptor when using the x-ray marker.The result is a mistreatment of ~4.5cm.

Manufacturer Narrative

The user used a procedure and adaptor from another device they previously used, a microselectron afterloader.The correct procedure was already discussed in the flexitron user manual.The applicable section of the flexitron user manual is re-distributed ((b)(4)) in a product bulletin.The redistributed information emphasizes again the correct workflow.

• Brand Name: FLEXITRON
• Type of Device: SYSTEM, APPLICATOR< RADIONUCLIDE, REMOTE_CONTROLLED
• Manufacturer (Section D): NUCLETRON; waardgelder 1; veenendaal, 3905 TH; NL 3905 TH
• Manufacturer Contact: gpms gpms ; elekta ltd; linac house, fleming way,; crawley, uk RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5430309
• MDR Text Key: 38004564
• Report Number: 9611894-2016-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HDR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other