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

Model Number	1002248
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.Serial numbers - (b)(4).
Event or Problem Description
The customer reported that during the mr scan whilst using the frame patients have experienced burn marks.Based on the available information actual injury has occurred.
Additional Manufacturer Narrative
(b)(4).

• 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: 7718229
• Report Number: 9612186-2018-00002
• Device Sequence Number: 11011830
• Product Code: HAW
• UDI-Device Identifier: 07340048306348
• UDI-Public: 07340048306348
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 1002248
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1