NEXUS® STANDARD HANDPIECE
Report
- Report Number
- 2435119-2023-00018
- Event Type
- Injury
- Date Received
- October 20, 2023
- Date of Event
- September 19, 2023
- Report Date
- October 20, 2023
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K231117
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2023, MISONIX LLC., A BIOVENTUS CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® STANDARD HANDPIECE, (PART NUMBER 100-21-0001, SERIAL NUMBER (B)(6)) WHILE USING A NEXUS® DIAMOND SHAVER AND IRRIGATION TUBING KIT (PART NUMBER 110-31-1230) DURING A TUMOR RESECTION PROCEDURE THAT OCCURRED ON (B)(6) 2023. THE REPORT INDICATED THE "SURGEON WENT TO USE THE HANDPIECE FOR THE FIRST TIME AND THE HANDPIECE WAS SO HOT IT BURNED THE SURGEON THROUGH HIS GLOVE. THE SURGEON USED THE HANDPIECE TO FINISH THE CASE AND IT DID NOT HAPPEN AGAIN." THE MISONIX REPRESENTATIVE FOR THE ACCOUNT CONFIRMED THE HANDPIECE REACHED A TEMPERATURE THAT WAS HIGH ENOUGH TO BURN THE SURGEON THROUGH TWO PAIRS OF GLOVES. THE DEGREE OF THE BURN WAS NOT REPORTED. PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. THE EFFECTS OF THE EVENT WERE LIMITED TO THE SURGEON. THE LOT NUMBER FOR THE NEXUS ® DIAMOND SHAVER AND IRRIGATION TUBING KIT (PART NUMBER 110-31-1230) WAS NOT REPORTED; THEREFORE, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED. THE DEVICE HISTORY RECORD FOR THE NEXUS® STANDARD HANDPIECE, (PART NUMBER 100-21-0001, SERIAL NUMBER (B)(6)) WAS REVIEWED. THE REVIEW INDICATED THE HANDPIECE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT DISPOSABLE PROBE TIP USED AT THE TIME OF THE EVENT WAS NOT RETURNED TO MISONIX FOR EVALUATION. THE SUBJECT HANDPIECE WAS RETURNED TO MISONIX WITH A DAMAGED CABLE. THE EXTREME CABLE DEFORMATION INDICATES THAT THE PRODUCT WAS USED OUTSIDE OF PRESCRIBED USE AND/OR PROCESSING GUIDELINES. NO ISSUES OR ANOMALIES WERE OBSERVED DURING INTERNAL TESTING OF THE HANDPIECE. TESTING CONFIRMED THE HANDPIECE OPERATED WITHIN SPECIFICATIONS. NO DEFECTS WERE NOTED THAT WOULD CAUSE OR CONTRIBUTE TO A USER BURN. THE HANDPIECE EXHIBITED NORMAL OPERATION AND FUNCTION. DUE TO THE NATURE IN WHICH ULTRASONIC DEVICES TRANSFER ENERGY INTO THE TARGET TISSUE, THERMAL EVENTS MAY OCCUR. A REVIEW OF POST-MARKET SURVEILLANCE INFORMATION DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS FOR THERMAL INJURY TO THE PATIENT OR USER. THE MISONIX REPRESENTATIVE CONFIRMED THE SURGEON HAS BEEN CONTINUALLY USING THE NEXUS® SYSTEM IN ADDITIONAL CASES SINCE THE INCIDENT WITHOUT RECURRENCE. THE INVESTIGATION HAS BEEN CONCLUDED. SECTION 5 OF THE THE NEXUS® STANDARD HANDPIECE INSTRUCTIONS FOR USE MANUAL (100-21-1000, REVISION D) CONTAINS INSTRUCTIONS ON CLEANING AND STERILIZATION OF THE HANDPIECE PRIOR TO USE. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION J) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS REGARDING THE SURGICAL TECHNIQUE AND DEVICE SETTINGS REQUIRED TO PREVENT THERMAL INJURY TO THE PATIENT OR USER: 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. POTENTIAL BURN HAZARD. WARNING: NEXUS® PROBES HAVE A SILICONE OR HARD PLASTIC SHEATH. COMPRESSING OR BENDING THE SHEATH MAY CAUSE THE SHEATH TO CONTACT THE VIBRATING SURFACE ALONG THE LENGTH OF THE PROBE OR AT THE PROBE TIP AND MAY CAUSE EXCESSIVE HEATING, WHICH MAY BURN USER OR PATIENT TISSUE AT THE SURGICAL SITE. WARNING: EXCESSIVE LOADING OF NEXUS® PROBES AT THE SURGICAL SITE MAY INDUCE HEATING DUE TO VIBRATION AND FRICTION AS TARGET TISSUE IS FRAGMENTED AND EMULSIFIED. IT IS CRITICAL TO MANAGE THE TEMPERATURE OF THE PROBE BY ADJUSTING THE IRRIGATION, ASPIRATION, AND ULTRASOUND SETTINGS, AND SURGICAL TECHNIQUE. TISSUE NECROSIS MAY RESULT IF PROBE TIP IS NOT MOVED RELATIVE TO TISSUE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC PROBE TIP AND MINIMIZE HEAT BUILD-UP. WHEN LATERAL MOTION IS NOT POSSIBLE WITHDRAW AND RE-INSERT PROBE TIP FREQUENTLY. WARNING: CONTACT TO VIBRATING ELEMENTS LIKE AN EXTENSION AND ULTRASONIC PROBE TIP MAY CAUSE BURNS AND SHOULD BE AVOIDED BY ALL MEANS. THE HANDPIECE SHOULD ONLY BE HELD AT THE BLACK HANDPIECE HOUSING AREA AND/OR THE BLACK HARD SHEATH. WARNING: A PROTECTIVE SILICONE SLEEVE, INCLUDED WITH CERTAIN PROBE TIPS, REDUCES THE RISK OF THERMAL DAMAGE BUT DOES NOT ELIMINATE IT. CONTACT WITH THE SILICONE SLEEVE SHOULD BE AVOIDED OR KEPT BRIEF WITH MINIMAL AMOUNT OF CONTACT PRESSURE. PRESSURE AND EXTENDED EXPOSURE CAN STILL RESULT IN EXCESSIVE FRICTIONAL HEAT AND CAUSE BURNS. WARNING: CONTACT OF THE RIGID OR SILICONE SHEATHS WITH PATIENT TISSUE UNDER PRESSURE, MAY CREATE A BURN HAZARD. AVOID CONTACT OF SHEATH ELEMENTS WITH PATIENT TISSUE UNDER PRESSURE. WARNING: PROBE TIP TEMPERATURES MAY EXCEED THE TISSUE NECROSIS POINT IF INSUFFICIENT IRRIGANT IS PRESENT AT THE PROBE TIP-TISSUE INTERFACE. FOR HARD TISSUE REMOVAL, ALWAYS USE THE MAXIMUM IRRIGATION FLOWRATE THAT DOES NOT AFFECT THE SURGICAL FIELD OF VIEW, OR IMPACT SURGICAL TECHNIQUE. ADDITIONAL EXTERNAL IRRIGATION, E.G., BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL PROBE TIP PORTION, MAY BE NECESSARY FOR REMOVAL OF VERY DENSE, HARD OSSEOUS STRUCTURES. WARNING: HARD TISSUE APPLICATIONS, A MINIMUM IRRIGATION SETTING OF 20 IS RECOMMENDED TO MINIMIZE OR PREVENT THERMAL INJURY AND/OR TISSUE NECROSIS. CAUTION: INSUFFICIENT IRRIGATION AND HIGH TIP PRESSURE (LOADING) UNDER EXTENDED EXPOSURE, E.G., IN TIGHT CAVITIES, ARE TO BE AVOIDED WHILE REMOVING HARD TISSUE. IT IS RECOMMENDED TO WITHDRAW AND RE-INSERT THE ULTRASONIC TIPS (E.G., BLADES & SHAVERS) REPEATEDLY TO RE-ESTABLISH ADEQUATE COOLING AND LUBRICATION. CAUTION: ADDITIONAL EXTERNAL IRRIGATION, E.G., BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL TIP PORTION, MAY BE NECESSARY WHEN REMOVING VERY DENSE, HARD OSSEOUS STRUCTURES. CAUTION: PRIME THE IRRIGATION TUBING PRIOR TO USE. AT ALL TIMES ENSURE THAT THE IRRIGATION FLOWS TOWARDS THE HANDPIECE WHEN FOOTSWITCH IS DEPRESSED. IF NO IRRIGATION IS FLOWING, CEASE USE UNTIL FLOW IS RESTORED.
ON (B)(6) 2023, MISONIX LLC., A BIOVENTUS CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® STANDARD HANDPIECE, (PART NUMBER 100-21-0001, SERIAL NUMBER (B)(6)) WHILE USING A NEXUS® DIAMOND SHAVER AND IRRIGATION TUBING KIT (PART NUMBER 110-31-1230). DURING A TUMOR RESECTION PROCEDURE THAT OCCURRED ON (B)(6) 2023. THE REPORT INDICATED THE "SURGEON WENT TO USE THE HANDPIECE FOR THE FIRST TIME AND THE HANDPIECE WAS SO HOT IT BURNED THE SURGEON THROUGH HIS GLOVE. THE SURGEON USED THE HANDPIECE TO FINISH THE CASE AND IT DID NOT HAPPEN AGAIN." THE MISONIX REPRESENTATIVE FOR THE ACCOUNT CONFIRMED THE HANDPIECE REACHED A TEMPERATURE THAT WAS HIGH ENOUGH TO BURN THE SURGEON THROUGH TWO PAIRS OF GLOVES. THE DEGREE OF THE BURN WAS NOT REPORTED. PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. THE EFFECTS OF THE EVENT WERE LIMITED TO THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1983661 | NEXUS® STANDARD HANDPIECE | ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE, | LFL | MISONIX, INC. | 100-21-0001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |