FDA Adverse Event Malfunction Summary report: N

VISUALASE

MDR report key: 22888852 · Received August 25, 2025

Report

Report Number: 1723170-2025-03057
Event Type: Malfunction
Date Received: August 25, 2025
Date of Event: July 30, 2025
Report Date: August 25, 2025
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: GAH
UDI-DI: 00763000416461
PMA / PMN Number: K081656
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H3/H6: ANALYSIS WAS COMPLETED FOR THIS EVENT. AS REPORTED, THE BONE ANCHOR WAS CRACKED WITHIN THE SEALED PACKAGE. CODES B01, C07, AND D02 APPLY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE ANCHOR BOLT IN THE ACCESSORIES KIT, INSPECTED PRIOR TO SCRUB OPENING THE STERILE PACKAGING, AND THE WHITE PLASTIC PORTION OF THE BOLT WAS CRACKED. A BACKUP PRODUCT WAS USED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1341653	VISUALASE	STYLET, SURGICAL, GENERAL & PLASTIC SURGERY	GAH	MEDTRONIC NAVIGATION, INC.	9735571	2025010024	00763000416461

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR	Male