MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE ICON; SYSTEM, RADIATION THERAPY, RADIONUCLIDE

Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	08/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event has been resolved for the affected machine.Further investigation is ongoing.
Event or Problem Description
During unloading of sources by elekta engineers, six sleeves came loose and later on when the emergency port had been opened, an additional six sleeves were also considered to be loose.
Additional Manufacturer Narrative
During initial loading of the cobalt sources of a gamma knife, loose source assembly lock rings were found.The lock rings were then put correctly into place on that particular machine before loading.However, an extra check during manufacturing was introduced in 2015 and this extra check is expected to detect any loose lock rings.Units manufactured after that date are therefore expected to be correct.The concerned machine was manufactured before that date.When analyzing the risks associated with loose lock rings, i.E.That source assemblies move out of position and affecting the delivered dose, it was found that the severity of the risk is a slight underdose (marginal) in correct position and that the probability is improbable (within acceptable region).The issues have been resolved for the affected machine and measures to check other machines due for installation or reload have already been implemented.

• Brand Name: LEKSELL GAMMA KNIFE ICON
• Common Device Name: SYSTEM, RADIATION THERAPY, RADIONUCLIDE
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• MDR Report Key: 6851232
• Report Number: 9612186-2017-00010
• Device Sequence Number: 16308604
• Product Code: IWB
• UDI-Device Identifier: 07340048305587
• UDI-Public: 07340048305587
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K160440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 08/12/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1