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

Model Number	002-1100
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a soft tissue ablation.It was reported that there was an issue with the vclas 001-4000.4 mm core fiber 10 mm tip set.The laser reportedly wouldn't function, and upon further inspection, it was found that the sheathing inside of the packaging was damaged.They switched to another kit to proceed.Issue occurred intra/peri-operatively with 20 minutes delay to surgical time.There was no reported impact on patient outcome.

• Brand Name: VISUALASE
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8613852
• Report Number: 1723170-2019-02375
• Device Sequence Number: 16774817
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR