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

Model Number	11.1
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The matchport is mounted in the gantry module.For version 11.1, the matchport device must be configured in a special way.This special configuration of the matchport device is described in the installation manual but not in the corrective maintenance manual.After the exchange of the gantry module, the matchport device may thus not be configured properly resulting in risk to the service technician or malfunction of the gantry.If the service technician does a kv generator calibration after the exchange, the technician will find out that the configuration is missing because they would not be able to perform the calibration.
Event or Problem Description
When replacing a faulty gantry module on a new installation, it was discovered that settings controlling the kv generator using lantronix/matchport were lost as they are stored locally in the gantry module.

• 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: 6445391
• Report Number: 9612186-2017-00004
• Device Sequence Number: 976830
• 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
• Report Date (Section B): 03/30/2017

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
• Device Model Number: 11.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1