SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM
Report
- Report Number
- 2435119-2022-00010
- Event Type
- Malfunction
- Date Received
- December 23, 2022
- Date of Event
- October 27, 2022
- Report Date
- February 11, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K062471
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2022, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT OF A GENERATOR FAILURE ON A SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER SYSTEM-M360-0, SERIAL NUMBER (B)(4) THAT OCCURRED ON (B)(6) 2022, DURING A LIVER PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS A "GENERATOR FAILURE DURING PROCEDURE." ELECTRICAL ERROR CODES "E1, E2, E3" WERE DISPLAYED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON (B)(6) 2022, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER OF 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM (PART NUMBER SYSTEM-M360-0, SERIAL NUMBER (B)(4). SERIAL NUMBER (B)(4_ WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE DEVICE. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. A REVIEW OF ALL POST-MARKET SURVEILLANCE INFORMATION INVOLVING THE SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER SYSTEM-M360-0) DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. NO OTHER REPORTS WERE RECEIVED ON THE SUBJECT SERIAL NUMBER (B)(4). THE CURRENT FREQUENCY OF PRODUCT OCCURRENCE REPORTS INVOLVING THE SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM IS WITHIN THE FREQUENCY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THEREFORE, THERE IS NO CHANGE IN THE BENEFIT-RISK RATIO ESTIMATED IN THE RISK MANAGEMENT REPORT AND NO FURTHER CORRECTIVE ACTION IS REQUIRED. THE INSTRUCTIONS FOR USE MANUAL (IFU-607, REVISION H) FOR SONASTAR® MODELS WITH SERIAL #'S THAT BEGIN WITH FHF CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS TO MITIGATE HARM FROM DELAY IN TREATMENT: WARNING 1.2 THE SONASTAR® 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 6.10 THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING THE PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. CAUTION 6.2 IT IS STRONGLY ADVISED THAT A STERILE BACKUP HANDPIECE BE READILY AVAILABLE IN THE OPERATING ROOM AS INSURANCE AGAINST ANY CONTAMINATION OR MALFUNCTION OF THE HANDPIECE DURING SURGERY. A COMPLETE LIST OF ALL WARNINGS, CAUTIONS AND NOTES CAN BE FOUND IN CHAPTER 1.1 OF THE IFU. THE SYSTEM DISPLAYED ELECTRICAL FAULT MESSAGES. THE SYSTEM MEETS THE REQUIREMENTS FOR LEAKAGE CURRENT IN ACCORDANCE WITH UL 60601-1 MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR SAFETY, AND IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (3RD EDITION) FOR ALL NORMAL AND SINGLE FAULT CONDITIONS FOR TYPE B APPLIED PARTS. SPECIFICALLY, THE GENERATOR CONSOLE MONITORS THE ELECTRICAL OUTPUT TO THE HANDPIECE AT ALL TIMES. IF THERE IS AN IMBALANCE OF CURRENT THE GENERATOR AUTOMATICALLY DISABLES THE ULTRASOUND OUTPUT TO PREVENT UNSAFE PATIENT OR USER LEAKAGE CURRENT. FAULT CODES ARE DISPLAYED ON THE FRONT PANEL AND AN AUDIBLE TONE CAN BE HEARD. THE PATIENT CIRCUIT IS A FLOATING GROUND, LIMITING LEAKAGE CURRENT. THE IFU LISTS CORRECTIVE ACTIONS TO CLEAR FAULT MESSAGES OR RETURN THE DEVICE TO MISONIX IF FAULT MESSAGES RECUR. WHILE THE REPORT WAS FOR A GENERATOR FAILURE, THE REPORTED ELECTRICAL ERROR CODES COULD APPLY TO THE HANDPIECE AND PROBE AS WELL. THE HANDPIECE PART NUMBER AND SERIAL NUMBER, AND THE DISPOSABLE PROBE TIP PART NUMBER AND LOT NUMBER, WERE NOT REPORTED, AND THEY WILL NOT BE RETURNED FOR EVALUATION. THE SUBJECT GENERATOR HAS NOT YET BEEN RETURNED TO MISONIX FOR EVALUATION. FURTHER INVESTIGATION COULD NOT BE CONDUCTED. UPON RETURN A FULL ENGINEERING EVALUATION WILL BE COMPLETED TO ESTABLISH POSSIBLE ROOT CAUSE OF THE NON-CONFORMANCE.
FOLLOW UP # 1: THE SUBJECT GENERATOR WAS RETURNED TO MISONIX FOR EVALUATION. VISUAL INSPECTION CONFIRMED A LOOSE EXTERNAL FILTER AS RECEIVED. A LOOSE EXTERNAL FILTER DOES NOT CAUSE OR CONTRIBUTE TO AN ELECTRICAL FAULT. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAULT COULD NOT BE CONFIRMED. THE GENERATOR WAS REPAIRED BY REWORKING THE EXTERNAL FILTER. ALL INSPECTION AND TEST RESULTS WERE IN CONFORMANCE WITH MISONIX'S SPECIFICATIONS AFTER THE REPAIR. THE INVESTIGATION HAS BEEN CONCLUDED.
ON (B)(6) 2022, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT OF A GENERATOR FAILURE ON A SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER SYSTEM-M360-0, SERIAL NUMBER (B)(4) THAT OCCURRED ON (B)(6) 2022, DURING A LIVER PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS A "GENERATOR FAILURE DURING PROCEDURE." ELECTRICAL ERROR CODES "E1, E2, E3" WERE DISPLAYED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON (B)(6) 2022, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER OF 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED.
ON NOVEMBER 4, 2022, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT OF A GENERATOR FAILURE ON A SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER SYSTEM-M360-0, SERIAL NUMBER (B)(6) THAT OCCURRED ON (B)(6) 2022, DURING A LIVER PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS A "GENERATOR FAILURE DURING PROCEDURE." ELECTRICAL ERROR CODES "E1, E2, E3" WERE DISPLAYED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON (B)(6) 2022, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER OF 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2755366 | SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM | ULTRASONIC SURGICAL ASPIRATION SYSTEM | LFL | MISONIX, INC. | SYSTEM-M360-0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |