MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL COORDINATE FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 leksell system inaccuracy.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The user reported an offset of one or more of their leksell stereotactic systems when using it for dbs (deep brain stimulation).The direction of the deviation is unknown by elekta since no post-op images or information from the user have been provided.The size has been reported to be 2 mm.An extensive investigation has been completed and the arc has been verified to be within specification.The frame has been found to be out of specification and will be replaced, however it is not a probable root cause to this event.No patient injuries have been reported.

• Brand Name: LEKSELL COORDINATE FRAME
• 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: 9326679
• Report Number: 9612186-2019-00009
• Device Sequence Number: 16860449
• Product Code: HAW
• UDI-Device Identifier: 07340048306348
• UDI-Public: 07340048306348
• Combination Product (Y/N): N
• 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): 01/03/2020

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1