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

Device Problems Product Quality Problem (1506); No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

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

The customer reported a deviation on the left side of the elekta g-frame.

Event Description

The customer reported a deviation on the left side of the elekta g-frame.

Manufacturer Narrative

The system has not been investigated by elekta and it is not clear what the root cause is.The root cause of the deviation is unknown, however faulty parts have been excluded.The user has also purchased a target simulator to be able to check the system.

• 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: 8424032
• MDR Text Key: 139067859
• Report Number: 9612186-2019-00003
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07340048305075
• UDI-Public: 07340048305075
• Combination Product (y/n): N
• PMA/PMN Number: K152558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1