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

Model Number	002-1100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that, while in a soft neuro tissue ablation procedure, the damaged map showed that there was no damage for one of the four lasers in use.The site increased the wattage of the test and there was no damage presented on the model.The surgeon was noted to have put neuroform in the bone anchor before laser insertion but did not flush it out prior to placing the catheter and laser.Once the catheter was removed, neuroform was reported to be stuck to it.All other lasers in the procedure were noted to function as designed.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
The visualise cooling laser applicator catheter was returned to the manufacturer for analysis.The unit was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE GUIDED LASER ABLATION SYSTEM
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8864450
• Report Number: 1723170-2019-04382
• Device Sequence Number: 14002350
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 002-1100
• Device Catalogue Number: 002-1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 68