MAUDE Adverse Event Report: ECKERT & ZIEGLER BEBIG GMBH SAGINOVA; HDR BRACHYTHERAPY AFTERLOADER

Model Number SAGINOVA

Device Problem Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

The software problem had been observed in two clinics in (b)(6) and had been reported to us as complaints.In both cases the patient data had been saved before system shutdown so that the patient data were available.To avoid cases where the software problem might reoccur and the patient data are not saved, an urgent field safety notice was sent to all users of saginova devices on 18 march 2016.Competent authorities have been informed about this field safety corrective action including fda (mdrpolicy@fda.Hhs.Gov) on 22 march 2016.We took immediate action to install the electronic reporting at eckert & ziegler bebig.However the installation created considerable technical problems which took our it department considerable time to solve.Therefore the electronic reporting of this field safety correction has been delayed until now.We also had several questions on how to duly fill out this template if it is not an incident that is reported but a field safety corrective action.As we have not received a reply until now this template has been filled out to the best of our knowledge.Our competent authority in (b)(6) has closed the file on 19 april 2016.Software problem reproduced at bebig.

Event Description

Cases of lost patient treatment data have been reported to bebig.During system shutdown of the saginovacontrol software, valid data might be rejected and lost due to an error in the exception handling procedure by the software.The error can potentially affect every saginovasystem.Data that is already stored on the system and shown after system startup is not affected and remains available.Loss of the information about performed maintenance, quality assurance check or treatment fraction may cause inconsistency in the documentation and confusion of the user.This could result in the delivery of the wrong treatment session or repeated treatment of already delivered fractions and possibly cause adverse health consequences.The resolution of the issue will be available with the next saginovasoftware release scheduled for early july.Valid data is available as long as the system is not shut down and must be printed or saved as pdf files immediately after execution of the treatment procedure or maintenance check.Furthermore the user must check that the treatment fraction number during fraction import is consistent with the treatment plan and previous treatment reports.All saginova users must be informed that they have to comply with the preventative user actions as described in detail in the following section until the problem has been resolved with the new software release.Recommended user action i: print all quality assurance, maintenance and treatment reports directly after they have been generated or save all respective pdf-files on a secure file system, which is approved to store patient data.Recommended user action ii: double check the treatment fraction number during fraction import on the saginovacontrol console with the respective treatment plan from sagiplanand all existing treatment reports from saginova in case if the fraction numbers of newly imported fractions don't overlap with existing treatment reports, the treatment can be performed followed by recommended user action i.In case the fraction numbers of newly imported fractions do overlap with existing treatment reports, the import should be rejected and the following steps should be followed re-import the fraction(s) missing in the system.Import the fraction(s) that need to be treated next.Delete the fractions generated, as they are shown with a wrong status.Treat the fraction(s) as scheduled and follow by recommended user action i.

• Brand Name: SAGINOVA
• Type of Device: HDR BRACHYTHERAPY AFTERLOADER
• Manufacturer (Section D): ECKERT & ZIEGLER BEBIG GMBH; robert rössle str. 10; berlin, 13125 ; GM 13125
• Manufacturer (Section G): ECKERT & ZIEGLER BEBIG GMBH; robert rössle str. 10; berlin, 13125 ; GM 13125
• Manufacturer Contact: sven langer ; robert rössle str. 10; berlin, 13125 ; GM 13125 ; 0941084734
• MDR Report Key: 5758155
• MDR Text Key: 49256976
• Report Number: 1000310011-2016-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• PMA/PMN Number: K142986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAGINOVA
• Device Catalogue Number: SAGINOVA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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