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

Model Number	9735542
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9735719.Device evaluated by mfr: 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 being used for a neuro soft tissue ablation procedure.It was reported that intra-operatively, after the site had completed the ablation, the lower monitor went black.A manufacturer representative checked the connections to the back of the monitor but video did not reappear.The representative rebooted the system and the monitor changed between black and booting text then remained black.The representative powered off the system, and reseated all cable connections from the monitor to the computer.When the system powered back on the monitor was displaying video normally.The procedure was completed using the system and there was no reported impact to patient outcome.There was no reported surgical delay.The representative later noted that when the site was opening the scanner door to the magnetic resonance imaging (mri), the monitor flashed black but returned to normal.
Event or Problem Description
Medtronic received additional information that the system had been used with no monitor issues.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12331663
• Report Number: 1723170-2021-02095
• Device Sequence Number: 2826083
• Product Code: GEX
• UDI-Device Identifier: 00763000313364
• UDI-Public: 00763000313364
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 08/12/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 8 YR
• Patient Weight: 28