VISUALASE
Report
- Report Number
- 1723170-2023-01544
- Event Type
- Injury
- Date Received
- August 23, 2023
- Date of Event
- July 28, 2023
- Report Date
- February 27, 2024
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- GAH
- PMA / PMN Number
- K081656
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE 10-15 SEPARATE ABLATIONS PLANNED VIA FIVE FIBERS. THE SURGEON DID NOT FEEL THAT THERE WAS ADEQUATE TREATMENT WITH THE 2 ABLATIONS THAT WERE PERFORMED. ADDITIONAL SURGERY WAS PERFORMED. THE PATIENT WAS BROUGHT BACK FOR A LASER ABLATION SURGERY ON (B)(6) 2023.
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE SITE HAD PERFORMED TWO ABLATIONS ON THE FIRST FIBER. THAT TEMPERATURE MAP (TMAP) SEQUENCE WAS GETTING TOWARD THE END OF ITS ~20 MINUTE LENGTH, SO THEY STOPPED IT AFTER WATCHING THE TEMP RETURN TO BASELINE. THEY TURNED THE SALINE PUMP OFF WHILE SURGEON WAS IN THE ROOM DOING THE PULLBACK. A FEW MINUTES LATER, ANOTHER TMAP SCAN WAS STARTED AND SALINE PUMP TURNED BACK ON. A COUPLE MINUTES INTO THE SCAN, THE SURGEON TRIED TO DO A TEST DOES AND THE MANUAL LASER CONTROL WINDOW SAID "SOMETHING LIKE 'LASER CONNECTION ERROR.'" THEY CYCLED POWER ON THE LASER GENERATOR AND GOT SAME MESSAGE. THEY ENDED THE SESSION AND STARTED A NEW ONE. THAT TIME, THEY GOT THE "DO NOT CONNECT LASER! LASER PORT BUSY/UNAVAILABLE" MESSAGE IN THE MANUAL LASER CONTROL WINDOW. THEY THOUGHT THE USB CABLE THAT CONNECTED THE LASER TO THE COMPUTER MAY HAVE BECOME DISCONNECTED, SO THE LOCAL REPRESENTATIVE (CC) CHECKED THE BACK OF THE COMPUTER. WHILE CHECKING, THE COMPUTER SHUT OFF. THE CC CONFIRMED THE POWER CORD WAS STILL PLUGGED IN AND WAS IN A RED CONTINUOUS POWER OUTLET. THEY TRIED TURNING THE COMPUTER BACK ON AND THE LIGHT WAS RED INSTEAD OF THE USUAL BLUE AND IT DID NOT POWER ON. THIS WAS WHEN THEY NOTICED THAT THERE WAS SOME SALINE ON THE SHELF AND THAT IT RAN TOWARD THE BACK AND WAS DRIPPING DOWN ON THE COMPUTER. THEY UNPLUGGED SYSTEM AND ALL CABLES IN COMPUTER. THEY REMOVED COMPUTER FROM THE CART AND OPENED IT. THE LATCH WAS WET AND THERE WAS SALINE IN THE COMPUTER. THE COMPUTER WAS DRIED TO THE BEST OF THEIR ABILITY, BUT IT WOULD NOT TURN ON. THE SURGEON CANCELLED THE REST OF THE ABLATION. A T1 WITH CONTRAST SCAN WAS TAKEN TO EVALUATE THE ABLATION THAT HAD BEEN DONE. THE PATIENT WAS TAKEN BACK TO THE OR TO HAVE THE FIVE VISUALASE COOLING LASER APPLICATOR SYSTEMS (VCLAS) AND BOLTS REMOVED. AT THIS ACCOUNT, GOING BACK TO THE OR TO REMOVE THE VCLAS AND BOLTS WAS STANDARD PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR WHEN THE PROCEDURE WAS ABORTED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1364637 | VISUALASE | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | GAH | MEDTRONIC NAVIGATION, INC | 9735571 | - |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Male | Required Intervention| H |