MAUDE Adverse Event Report: ELEKTA INSTRUMENTS LEKSELL FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	1002248 FRAME G W STRAIGHT/CUR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient undergoing bilateral dbs electrode implant using leksell frame.One electrode was implanted, and ct used to check placement.Error was greater than acceptable or expected.The spare arc/ring was sterilized, and the electrode was reimplanted.Error was improved, but was not acceptable and not explainable by human error or natural deviations.The incision was closed.Intensive troubleshooting was performed.My partner was consulted as well for additional perspectives on causes.Additional scanning, and "phantom" targets that were non-invasive were targeted with the arc/ring.The leksell fiducial box was tested, with high but not unacceptable error per navigation system.Operation was aborted due to lack of functioning equipment; more than one possible malfunctioning piece of equipment, with a non-linear error that could not be resolved.

• Brand Name: LEKSELL FRAME
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENTS
• MDR Report Key: 18630647
• Report Number: MW5150997
• Device Sequence Number: 20856198
• Product Code: HAW
• UDI-Device Identifier: 07340048306348
• UDI-Public: 07340048306348
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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: Health Professional
• Device Catalogue Number: 1002248 FRAME G W STRAIGHT/CUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White