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

Model Number A0820-07

Device Problems Device Displays Incorrect Message (2591); Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

Mr fiducial box use error.

Manufacturer Narrative

H6 updated.H10 updated: following start up at a site elekta were informed about a user error relating to the mr fiducial box.Oil had been used instead of cuso4 as stipulated by the instruction for use.Use of oil is known from literature to cause shifts in the stereotactic reference.The issue has been solved at site with delivery of a new mr indicator box.Elekta has contacted the site to offer help in investigating the consequences of the use of oil.The site has not communicated to elekta that they would accept our help and has not informed elekta that they have reported any patient mistreatment as a consequence of the use of oil.

Event Description

Mr fiducial box use error.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• MDR Report Key: 9213183
• MDR Text Key: 193282543
• Report Number: 9612186-2019-00006
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07340048303019
• UDI-Public: 07340048303019
• Combination Product (y/n): N
• PMA/PMN Number: K173789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: A0820-07
• Device Lot Number: 6060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1