MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL GAMMAPLAN; SYSTEM,PLANNING,RADIATION THERAPY TREATMENT

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is an internal case where it was reported that there is a possible memory corruption in lgp 10.2 when creating fused studies via drag & drop.The manufacturer's investigation is ongoing to determine the risk, and if this issue has affected patient treatments.

Manufacturer Narrative

The manufacturer's investigation is currently on-going.Further information will be provided in the follow-up report.

Manufacturer Narrative

Results of manufacturer's final investigation (final report): the manufacturer's investigation found that the bug poses a risk for mistreatment in lgp 10.2, however they are not aware of any actual clinical mistreatments as a result of this issue.The risk was classified as consequence 4 (catastrophic) with probability at most 3 (remote).The manufacturer recommended that the problem is fixed in a new release that shall replace lgp 10.2 in the field.To reduce the probability of the problem in the field until that new release is available, users should be notified about the issue and how to avoid it (i.E.Told to not use drag and drop to create fused image studies, and use the image study menus instead).A field safety corrective action was initiated on 18th may 2015 under the following reference numbers: field safety notice: 100-01-102-015, field safety corrective action: fca-eiab-0002.The bug has been corrected in a new release and a service pack which will rectify the above mentioned error was released on 15th july 2015.The manufacturer is not aware of any similar incidents with this type of medical device with a similar root cause.The medical device has been distributed to the following countries: (b)(6); united states (us).

• Brand Name: LEKSELL GAMMAPLAN
• Type of Device: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: gpms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 4687936
• MDR Text Key: 20772330
• Report Number: 9612186-2015-00004
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• PMA/PMN Number: K103093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: LEKSELL GAMMAPLAN 10.2
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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