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

Model Number	1053958
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2020
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 been completed.
Event or Problem Description
The customer reported that the paint on the leksell vantage arc was flaking.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.There was no patient involvement.Upon inspection of the vantage arch system it was found that the system was worn and that in some parts the engraved paint had fallen off during the cleaning and sterilization procedure.When the paint disappears from the engravings, the scale is still visible due to the engravings being non-anodized and the aluminium colour will provide contrast to the dark anodization.The cleaning step that the site performs does not reveal any deviations from a standard cleaning and sterilization procedure in a way that could affect the paint adherence.

• 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: 10579054
• Report Number: 9612186-2020-00008
• Device Sequence Number: 1193075
• Product Code: HAW
• UDI-Device Identifier: 07340048304399
• UDI-Public: 07340048304399
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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
• Device Model Number: 1053958
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1