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

Model Number	9735560
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a soft tissue ablation neuro procedure.It was reported that the 10 millimeters core fiber tip stopped working mid procedure.The site did two pull backs with the fiber and everything worked fine.Then after a third pull back, the site could no longer see the test does of 20% on the tmap.The site restarted the tmap and tried again, but still it didn't show up.After restarting tmap and checking the laser for breaks, the site opened a new laser and replaced the old while the patient was still in the mri scanner.Changing the laser fiber worked and the site was able to finish the procedure as planned.There was no impact on the patient outcome.
Additional Manufacturer Narrative
Patient age not available from the site.Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE CORE FIBER
• 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: 12908726
• Report Number: 1723170-2021-02783
• Device Sequence Number: 4884482
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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 Expiration Date: 06/10/2023
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0222395613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male