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

Model Number	1002136
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
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
The customer reported that the headframe shifted during treatment.
Additional Manufacturer Narrative
G1-2 contact office - address updated.H6.Coding added.The investigation was completed by conducting a thorough evaluation of the reported information.It was reported that the headframe shifted during treatment and there was a mistreatment to a patient.Elekta visited the site and examined all fixation posts and screws which appeared to be in order.There is nothing that indicates that there is a malfunction to the g-frame itself.The frame is fixated towards various sizes, shapes and rigidity of the skull.The user should always ensure that the fixation is rigid enough to proceed with the treatment by performing a tug test and to ensure that the patient is monitored during the entire treatment.The root cause is not known.A possible cause could be that the g-frame has not been firmly attached to the skull of the patient, in combination with severe movement of the patient during gamma knife treatment.The information provided in leksell stereotactic system® instructions for use states that the user should ensure secure fixation and to check the fixation with a tug test together with warnings.This information is judged to be sufficient for proper handling of the device.

• 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: 9932583
• Report Number: 9612186-2020-00004
• Device Sequence Number: 2461908
• Product Code: HAW
• UDI-Device Identifier: 07340048305075
• UDI-Public: 07340048305075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1002136
• Device Lot Number: 6200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1