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

Model Number 9735542

Device Problem Material Fragmentation (1261)

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

Event Date 08/22/2019

Event Type  malfunction  

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 Description

Medtronic received information that, while closing up in a soft neuro tissue ablation procedure, the bone anchor was reported to have sheared off when removing it from the anatomy.It was reported that the remainder of the anchor could be removed from the skull.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.

Manufacturer Narrative

The bone anchor was returned to the manufacturer for evaluation.Testing found that the plastic portion of the anchor was cracked and the metal screw had broken free.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE GUIDED LASER ABLATION SYSTEM
• 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: 8929951
• MDR Text Key: 155502521
• Report Number: 1723170-2019-04624
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00643169792890
• UDI-Public: 00643169792890
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 105