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

Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been carried out, the outcome findings show an error was made during the installation of the device.The issue has been corrected by trained elekta operatives allowing the device to be returned to clinical use.
Event or Problem Description
During installation of leksell gamma knife icon it was identified by an elekta installation engineer that some of the internal wiring was not connected correctly.The device is not in clinical use.

• 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: 6386755
• Report Number: 9612186-2017-00001
• Device Sequence Number: 1102169
• Product Code: IWB
• UDI-Device Identifier: 07340048305587
• UDI-Public: 07340048305587
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K160440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: Service Personnel
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1