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

Model Number	1072447
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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
During verification of vantage frame adapter it was observed that there is a risk of shifting the frame versus the adapter in x-direction when holding the frame and adapter on the side.The interface is similar in the vantage frame holder and there is a risk that the same or similar shift can occur during handling.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and during development of a frame adapter for vantage have ascertained that there was a risk of inducing a shift when pressing the frame side versus the frame adapter side.This is the same for the frame holder used in ct and treatment for open surgery.It has been measured in worst case up to 0.68 mm shift in target as a result of gripping the side.This is the maximum value measured and the probability to occurrence of unacceptable values is estimated to (b)(4) of the cases.Now that the investigations have been completed, elekta have concluded that for open surgery the probability for a shift to cause any harm is implausible.No patient injuries or reports have been received from any customers.

• Brand Name: LEKSELL VANTAGE 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: 9473261
• Report Number: 9612186-2019-00012
• Device Sequence Number: 14150902
• Product Code: HAW
• UDI-Device Identifier: 07340048311410
• UDI-Public: 07340048311410
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 1072447
• Device Catalogue Number: 1072447
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 11/17/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1