NEXUS® SONASTAR ELITE HANDPIECE
Report
- Report Number
- 2435119-2024-00011
- Event Type
- Malfunction
- Date Received
- October 3, 2024
- Date of Event
- August 2, 2024
- Report Date
- February 11, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K231117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON AUGUST 02, 2024, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N: (B)(6) AND A NEXUS® SONASTAR ELITE HANDPIECE (P/N: 100-26-0000, S/N: (B)(6) DURING A BRAIN TUMOR ASPIRATION PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE AN "ELECTRICAL FAULT" ERROR MESSAGE WAS DISPLAYED ON THE CONSOLE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6) 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PATIENT REMAINED STABLE DURING THE DELAY BEFORE THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE. A BACK UP NEXUS® SONASTAR® ELITE HANDPIECE WAS NOT AVAILABLE. A NEXUS® SONASTAR® SHORT HANDPIECE WAS AVAILABLE BUT COULD NOT DELIVER THE CAPABILITIES TO ACCESS THE LOCATION OF THE BRAIN TUMOR. THE SURGEON RECOMMENDED MOVING FORWARD WITH A DIFFERENT METHOD OF TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® CONSOLE AND THE NEXUS® SONASTAR ELITE HANDPIECE IN USE AT THE TIME OF THE EVENT. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE DEVICES. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT CONSOLE WAS RETURNED TO MISONIX FOR EVALUATION. NO FAULT MESSAGES WERE OBSERVED DURING EVALUATION OF THE CONSOLE. A REVIEW OF ALL AVAILABLE POST MARKET SURVEILLANCE DATA HAS NOT SHOWN ADVERSE TRENDS RELATED TO THIS OR SIMILAR EVENTS. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY IN THE ORIGINAL RISK MANAGEMENT REPORT. THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION K) (IFU) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS: WARNING THE NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM IS INTENDED TO BE USED IN VARIOUS TYPES OF INVASIVE, SURGICAL PROCEDURES. THERE MAY BE INDIRECT DANGER TO THE PATIENT SHOULD THE DEVICE FAIL DURING THE PROCEDURE. IT IS RECOMMENDED THAT THE FACILITY FOLLOWS ITS BACK-UP EQUIPMENT PROTOCOLS. CAUTION THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. CAUTION IT IS STRONGLY ADVISED THAT A STERILE BACKUP HANDPIECE BE READILY AVAILABLE IN THE OPERATING ROOM AS INSURANCE ANY CONTAMINATION OR MALFUNCTION OF THE HANDPIECE USED DURING SURGERY. IN THE EVENT OF AN ELECTRICAL FAULT, THE MAIN SCREEN IS REPLACED BY ALERT SCREENS. REFER TO SECTION 9.1 FOR A DESCRIPTION OF THESE WARNINGS. THE CONSOLE MONITORS THE ELECTRICAL OUTPUT AT ALL TIMES AND ALERTS IN CASES WHERE THE HANDPIECE IS NOT PROPERLY CONNECTED TO THE CONSOLE, WHEN AN OUTPUT SHORT OR OPEN CIRCUIT IS DETECTED OR ELECTRICAL SAFETY IS COMPROMISED. AN ELECTRICAL FAULT SCREEN IS DISPLAYED TOGETHER WITH A STEADY AUDIBLE INDICATOR. ULTRASOUND AND IRRIGATION ARE DEACTIVATED. REQUIRES RECYCLING OF MAINS POWER SWITCH TO RE-SET. WARNING IMMEDIATELY SUSPEND OPERATION IF ELECTRICAL FAULT APPEARS ON DISPLAY AND/OR AN ELECTRICAL FAULT AUDIBLE INDICATOR SOUNDS. REMOVE ULTRASONIC TIP FROM SURGICAL SITE. TURN MAINS POWER OFF. DO NOT TOUCH ANY METALLIC PARTS OF HANDPIECE, EXTENSION, ULTRASONIC TIP OR GENERATOR WHILE FAULT IS INDICATED. POSSIBLE CAUSE & CORRECTIVE ACTION: 1. HANDPIECE NOT CONNECTED - TURN MAINS POWER OFF, CHECK HANDPIECE CABLE CONNECTION, RESTART CONSOLE. 2. DEFECTIVE HANDPIECE - TURN MAINS POWER OFF, REPLACE HANDPIECE AND RESTART CONSOLE, IF PROBLEM PERSISTS REPLACE CONSOLE. 3. DEFECTIVE CONSOLE - TURN MAINS POWER OFF, REPLACE CONSOLE. THE SUBJECT CONSOLE WAS RETURNED TO MISONIX FOR EVALUATION. NO FAULT MESSAGES WERE OBSERVED DURING EVALUATION OF THE CONSOLE. THE HANDPIECE HAS BEEN RETURNED BUT HAS NOT YET BEEN EVALUATED. A FOLLOW UP REPORT WILL BE ISSUED ONCE EVALUATION OF THE HANDPIECE IS COMPLETE.
FOLLOW UP # 1 THE SUBJECT HANDPIECE WAS RETURNED TO MISONIX FOR EVALUATION WITH A BROKEN TRANSDUCER SHAFT. INSPECTION AND TESTING CONFIRMED THE HANDPIECE DISPLAYED AN ELECTRICAL FAULT MESSAGE DURING EVALUATION. THE INVESTIGATION HAS BEEN CONCLUDED.
ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON AUGUST 02, 2024, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N: (B)(6) AND A NEXUS® SONASTAR ELITE HANDPIECE (P/N: 100-26-0000, S/N: (B)(6) DURING A BRAIN TUMOR ASPIRATION PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE AN "ELECTRICAL FAULT" ERROR MESSAGE WAS DISPLAYED ON THE CONSOLE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6) 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PATIENT REMAINED STABLE DURING THE DELAY BEFORE THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE. A BACK UP NEXUS® SONASTAR® ELITE HANDPIECE WAS NOT AVAILABLE. A NEXUS® SONASTAR® SHORT HANDPIECE WAS AVAILABLE BUT COULD NOT DELIVER THE CAPABILITIES TO ACCESS THE LOCATION OF THE BRAIN TUMOR. THE SURGEON RECOMMENDED MOVING FORWARD WITH A DIFFERENT METHOD OF TREATMENT.
ON AUGUST 06, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON AUGUST 02, 2024, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N: XA2521) AND A NEXUS® SONASTAR ELITE HANDPIECE (P/N: 100-26-0000, S/N: (B)(6) DURING A BRAIN TUMOR ASPIRATION PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE AN "ELECTRICAL FAULT" ERROR MESSAGE WAS DISPLAYED ON THE CONSOLE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6) 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PATIENT REMAINED STABLE DURING THE DELAY BEFORE THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE. A BACK UP NEXUS® SONASTAR® ELITE HANDPIECE WAS NOT AVAILABLE. A NEXUS® SONASTAR® SHORT HANDPIECE WAS AVAILABLE BUT COULD NOT DELIVER THE CAPABILITIES TO ACCESS THE LOCATION OF THE BRAIN TUMOR. THE SURGEON RECOMMENDED MOVING FORWARD WITH A DIFFERENT METHOD OF TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713956 | NEXUS® SONASTAR ELITE HANDPIECE | HANDPIECE | LFL | MISONIX, INC. | 100-26-0000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |