VISUALASE
Report
- Report Number
- 1723170-2025-03000
- Event Type
- Malfunction
- Date Received
- August 19, 2025
- Date of Event
- July 28, 2025
- Report Date
- September 29, 2025
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- GAH
- PMA / PMN Number
- K081656
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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.
H2) ADDITIONAL INFORMATION WAS ADDED TO B5. 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.
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.
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT-OF-BOX ISSUE WITH THE ANCHOR BOLT. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT "WHEN FULLY TIGHTENING THE BLUE CAP ON THE BOLT (WITHOUT LASER IN PLACE), CEREBROSPINAL FLUID (CSF) FLUID WAS STILL LEAKING". THE HCP "FEELS LIKE THE INNER GASKET SHOULD BE 'FIXED' SO THAT THE TIGHTENING OF THE CAP, WITHOUT LASER IN PLACE, WILL ALLOW FLUID TO NOT LEAK". THE BOLTS WERE PLACED FIRST, AND NOTHING WAS INSIDE THE BOLT WHEN TIGHTENING THE CAP. THERE WAS NO DELAY TO THE PROCEDURE.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO REPORTED IMPACT TO THE PATIENT. A NEW ANCHOR BOLT WAS USED FOR THE REMAINDER OF THE CASE. IT WAS STATED THAT "THIS IS SIMPLY SURGEON FEEDBACK FOR THE NEW ANCHOR BOLT."
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ANCHOR BOLT WAS NOT SWITCHED OUT, AND A NEW ONE WAS NOT OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2663534 | VISUALASE | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | GAH | MEDTRONIC NAVIGATION, INC. | 9736536 | 300013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Male |