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

Model Number	1053958
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection of the leksell vantage arc system it was found that the screw for the guide holder and the screw for the arc support slide had been mixed-up.The m4x10mm screw for the guide holder was used for the arc support slide instead of the m4x8mm screw.The screw protrudes 2mm more than the correct screw and will therefore interfere with the frame holder side.The device had not been used clinically, however the investigation found that if the screws were mixed-up and not detected prior to use that this may cause a small shift in the target.The root cause is use error.The ifu clearly describes the position of the two different screws as well as correct docking of the support arc.A change of design to the dimension of the stop and guide screws will eliminate the risk of mixing-up screws with leksell vantage arc system which will in turn eliminate the risk of tilting the arc support.This will be implemented in a future release.
Event or Problem Description
During inspection it was found that screws were incorrect positioned on the vantage system.

• Brand Name: LEKSELL VANTAGE ARC 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: 9920824
• Report Number: 9612186-2020-00006
• Device Sequence Number: 14267301
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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
• Device Model Number: 1053958
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1