MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Model Number	9735542
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a thermal therapy system.It was reported outside of a procedure that during configuration with a different companies mri system the software crashed while it was saving the configuration information.The error message showed "session manager busy".The only activity possible was to switch off the thermal therapy system's computer, but the error message remained active when the computer was restarted.After keeping the computer off for more than 30 minutes, the manufacturer representative tried to save the information again.No patient was present at the time of the event.Additional information was received stating that after 5 attempts the configuration was able to be saved.Two configuration were saved since the first was not working and the gateway field even if correctly typed was not saved and resulted empty.A second configuration was tried but after save data was tried to connect the system the whole system or software was blocked.Any key selection resulted in a message informing that the system manages was busy.No action was allowed even to shut down the system correctly.Only a hard shutdown was possible directly from the computer.Then 5 attempt were done and restarting the system but again no action were allowed and the return message was system manager busy.Then the system was hard shutdown again and the decision was wait more than 30 minutes before restarting it.After more than 30 minutes the system restart and was working but again the two configuration had some missing data even if all requested data were correctly typed.The two configuration were both deleted and a new configuration defined.Then the new configuration was working and able get connection of visualase with the scanner.

• Brand Name: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12917323
• Report Number: 1723170-2021-02797
• Device Sequence Number: 5658109
• Product Code: GEX
• UDI-Device Identifier: 00763000402082
• UDI-Public: 00763000402082
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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 Model Number: 9735542
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown