MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported a deviation on the left side of the elekta g-frame.
Event or Problem Description
The customer reported a deviation on the left side of the elekta g-frame.
Additional Manufacturer Narrative
The system has not been investigated by elekta and it is not clear what the root cause is.The root cause of the deviation is unknown, however faulty parts have been excluded.The user has also purchased a target simulator to be able to check the system.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• MDR Report Key: 8424032
• Report Number: 9612186-2019-00003
• Device Sequence Number: 1341312
• Product Code: HAW
• UDI-Device Identifier: 07340048305075
• UDI-Public: 07340048305075
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K152558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1