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

Model Number 9735542

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No products have been returned to medtronic for analysis.A system check out was not completed as the instrument was replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a manufacturer representative regarding a navigation device being used for a soft tissue ablation (neuro) procedure.It was reported that the tip came off in the clearpoint cannula outside of the skull.There was no known impact on patient outcome and no delay of time with the procedure.

• Brand Name: VISUALASE
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8583009
• MDR Text Key: 144159815
• Report Number: 1723170-2019-02179
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00643169655935
• UDI-Public: 00643169655935
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2019

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
• Device Operator: Health Professional
• Device Model Number: 9735542
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 103