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

Model Number	A0820-07
Medical Device Problem Code	Compatibility Problem (2960)
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
Mr fiducial box use error.
Additional Manufacturer Narrative
H6 updated.H10 updated: following start up at a site elekta were informed about a user error relating to the mr fiducial box.Oil had been used instead of cuso4 as stipulated by the instruction for use.Use of oil is known from literature to cause shifts in the stereotactic reference.The issue has been solved at site with delivery of a new mr indicator box.Elekta has contacted the site to offer help in investigating the consequences of the use of oil.The site has not communicated to elekta that they would accept our help and has not informed elekta that they have reported any patient mistreatment as a consequence of the use of oil.
Event or Problem Description
Mr fiducial box use error.

• 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: 9213183
• Report Number: 9612186-2019-00006
• Device Sequence Number: 11490929
• Product Code: HAW
• UDI-Device Identifier: 07340048303019
• UDI-Public: 07340048303019
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: No Information
• Device Model Number: A0820-07
• Device Lot Number: 6060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1