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

Model Number	1055007
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During an internal check of a leksell vantage stereotactic arc system it was discovered that a faulty locking piece of the instrument carrier did not meet the requirement of locking force to the arc.In systems with the faulty locking piece there is a risk that the instrument carrier is insufficiently locked even after tightening the knob firmly.The instrument carrier may in some instances be moved along the arc when forces below the specified requirement are applied, which may lead to an instrument introduced into the brain moving out of the planned trajectory and may cause injury.The root cause has been found to be a manufacturing error on an inner radius of the locking piece.The part has been manufactured out of specification.An important field safety notice (b)(4) will be sent to all affected customers on (b)(6) 2020.Replacement of faulty carriers is estimated to be released (b)(6) 2020.
Event or Problem Description
During an internal inspection of two vantage arc systems, it was found that the arc carrier was unable to lock securely.

• 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: 9872404
• Report Number: 9612186-2020-00003
• Device Sequence Number: 13573352
• Product Code: HAW
• UDI-Device Identifier: 07340048304887
• UDI-Public: 07340048304887
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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?: Yes
• Operator of Device: Other
• Device Model Number: 1055007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1