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

Model Number 1053958

Device Problems Flaked (1246); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the paint on the leksell vantage arc was flaking.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.There was no patient involvement.Upon inspection of the vantage arch system it was found that the system was worn and that in some parts the engraved paint had fallen off during the cleaning and sterilization procedure.When the paint disappears from the engravings, the scale is still visible due to the engravings being non-anodized and the aluminium colour will provide contrast to the dark anodization.The cleaning step that the site performs does not reveal any deviations from a standard cleaning and sterilization procedure in a way that could affect the paint adherence.

• 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: 10579054
• MDR Text Key: 226110289
• Report Number: 9612186-2020-00008
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07340048304399
• UDI-Public: 07340048304399
• Combination Product (y/n): N
• PMA/PMN Number: K190887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1053958
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1