SONASTAR ULTRASONIC SURGICAL ASPIRATOR MONOPOLAR RF CABLE
Report
- Report Number
- 2435119-2017-00004
- Event Type
- Malfunction
- Date Received
- September 7, 2017
- Report Date
- September 5, 2017
- Manufacturer
- MISONIX INC.
- Product Code
- LFL
- UDI-DI
- 00841626100572
- PMA / PMN Number
- K062471
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
A REPORT WAS RECEIVED FROM (B)(6), THE PRC DISTRIBUTOR AND LEGAL AGENT FOR MISONIX INC. THAT IS NO LONGER UNDER CONTRACT WITH MISONIX, INC. NO PATIENT OR USER INJURY WAS REPORTED. A MALFUNCTION WITH THE MONOPOLAR COAGULATION SYSTEM WIRE AND CONNECTOR WAS REPORTED. THE VERBATIM REPORT FOLLOWS: (B)(6) VERY RECENTLY RECEIVED A MALFUNCTION REPORT FROM (B)(6) HOSPITAL: WHEN USING COAG FUNCTION WITH VALLEY LAB FX, AFTER THE FOOTSWITCH WAS PRESSED, NAKED FLAME WAS FOUND AT THE CONNECTION PART BETWEEN SONASTAR AND VALLEY LAB FX , AND THE CABLE WAS BURNED AS CONFIRMED BY THE PHOTOS. THEN HEAD NURSE TURNED OFF THE SYSTEM, CHECKED BOTH SONASTAR AND RF GENERATOR, BUT FOUND THE TWO MACHINES WERE CONNECTED PROPERLY, BOTH MACHINES WERE FUNCTIONAL AND WORKED WELL. NOW THE HOSPITAL IS CONSIDERING REPORTING THIS TO (B)(6) AS AN ADVERSE EVENT. PLEASE MAKE SURE TO CONTACT THE HOSPITAL AS SOON AS POSSIBLE ABOUT THIS SITUATION, THE CONTACT PERSON AT THE HOSPITAL IS (B)(6). DESCRIPTION AND INTENDED USE OF THE SONASTAR® UTLRASONIC SURGICAL ASPIRATOR SYSTEM: THE SONASTAR® ULTRASONIC ASPIRATOR SYSTEM (HEREINAFTER SONASTAR) IS DESIGNED FOR THE USE IN THE FRAGMENTATION, EMULSIFICATION AND ASPIRATION OF BOTH SOFT AND HARD (I.E. BONE) TISSUE IN A NUMBER OF SURGICAL SPECIALTIES. THE SONASTAR IS A FULLY SELF-CONTAINED CONSOLE WITH BUILT-IN IRRIGATION, ASPIRATION AND VIBRATION FUNCTIONS. THE HANDPIECE, CONNECTED TO A MICROPROCESSOR BASED CONSOLE, WORK TOGETHER TO PROVIDE PRECISE SURGICAL TISSUE ABLATION AND REMOVAL. THE SONASTAR CAN ALSO BE COMBINED WITH AN APPROVED ELECTROSURGICAL UNIT TO FACILITATE CAUTERY IN THE MONOPOLAR COAGULATION MODE. APPROVED ELECTROSURGICAL UNITS ARE LISTED IN THE IFU MANUAL. THE SONASTAR IS DESIGNED TO THE DELIVERY OF RF ENERGY VIA ITS INSTRUMENTS, FROM APPROVED ELECTROSURGICAL UNITS. ALTHOUGH THESE ELECTROSURGERY UNITS SUPPORT BIPOLAR AND MONOPOLAR INSTRUMENTS, AS WELL AS CUT AND COAG MODES, THE SONASTAR IS DESIGNED FOR USE IN MONOPOLAR COAG MODE ONLY. THE RF ENERGY IS DELIVERED VIA A CABLE CONNECTING THE SONASTAR HP TO THE RF GENERATOR, THROUGH THE HANDPIECE AND THE PROBE, WHERE IT CONTACTS TISSUE. THE PATIENT IS FITTED WITH ONE OR MORE GROUND PADS, AS PER COMMON MONOPOLAR ELECTROSURGERY PRACTICE. THE CABLE SUBJECT OF THIS COMPLAINT IS THE SINGLE USE STERILE MONOPOLAR HANDPIECE CABLE. THE STERILE PRODUCT NUMBER IS CSFM6-D050. THE CONNECTOR SUBJECT OF THIS COMPLAINT IS (B)(4) 8MM MONOPOLAR RF CABLE CONNECTOR. THE SMALL SOCKET END OF THE MONOPOLAR CABLE IS PLUGGED INTO THE ELECTROSURGICAL PIN RECEPTACLE LOCATED IN THE REAR CAP OF THE HANDPIECE. THE LARGE MALE BRASS CONNECTOR END OF THE CABLE IS PLUGGED INTO CONNECTOR. THE CONNECTOR IS PLUGGED INTO THE ELECTROSURGERY UNIT. A SECOND NONSTERILE UMBILICAL CABLE IS SUPPLIED BY MISONIX INC. TO CONNECT THE ELECTROSURGICAL GENERATOR FOOTSWITCH CONNECTOR INTO THE SONASTAR GENERATOR CONNECTOR. THIS CONNECTION PERMITS THE SONASTAR FOOTSWITCH TO CALL FOR ELECTRICAL CURRENT FROM THE ELECTROSURGICAL GENERATOR TO THE SONASTAR INSTRUMENTS. THE UMBILICAL IS NOT THE SUBJECT OF THIS COMPLAINT. MISONIX INC. RECOMMENDS REFERRING TO THE USER MANUAL SUPPLIED WITH THE ELECTROSURGICAL GENERATOR FOR ALL SETTING, CONVENTIONS, AND SAFETY GUIDELINES. TO USE THE COAG FEATURE, THE COAG BUTTON ATOP THE SONASTAR FOOTSWITCH MAY BE DEPRESSED FOR COAG ONLY OPERATION, OR THE VIBRATION + COAG PEDAL ON THE RIGHT HAND SIDE OF THE FOOTSWITCH MAY BE DEPRESSED FOR SIMULTANEOUS OPERATION. MISONIX RECOMMENDS STAYING WITHIN THE LIMITS PRESCRIBED BY THE ELECTROSURGICAL GENERATOR'S USER MANUAL FOR THE TYPE OF PROCEDURE BEING PERFORMED, UP TO A MAXIMUM POWER SETTING OF 70W. GENERALLY, THE LOWER SETTING THAT PROVES EFFECTIVE FOR THE PROCEDURE BEING PERFORMED SHOULD BE USED. DURING ACTIVATION OF THE COAG BUTTON, THERE IS NO IRRIGATION PRESENT AT THE TIP. WHEN THE VIBRATION + COAG PEDAL IS ACTIVATED, IRRIGATION WILL FLOW TO THE TIP AT A PRESET LEVEL. INVESTIGATION: MISONIX INC. CONTRACTED (B)(6) TO ACT AS A LIAISON BETWEEN MISONIX AND THE (B)(6) HOSPITAL TO INVESTIGATE THE COMPLAINT. A COPY OF THE MISONIX INC. INVESTIGATION OF CLINICAL COMPLAINTS FORM IS INCLUDED AS ATTACHMENT (B)(6) ATTEMPTED TO ARRANGE A CONFERENCE CALL WITH THE CONTACT PERSON FROM THE HOSPITAL TO COMPLETE THE FORM. THE CONTACT PERSON STATED THAT HOSPITAL MANAGEMENT WOULD NOT ALLOW THE HOSPITAL TO SPEAK TO MANUFACTURER OR (B)(6) ON THIS EVENT. THEY RECOMMENDED THAT THEY SPEAK WITH THE DISTRIBUTOR THAT IS NO LONGER UNDER CONTRACT WITH MISONIX INC. A SECOND ATTEMPT WAS MADE BY THE (B)(6) LIAISON TO AT LEAST OBTAIN THE PRODUCT NUMBER, LOT NUMBER, AND ARRANGE A RETURN THE CABLE AND CONNECTOR SUBJECT OF THE EVENT TO MISONIX INC., AT MISONIX INC. COST INCLUDING A REPLACEMENT FOR THE SUBJECT CABLE AND CONNECTOR. THE HOSPITAL AGAIN DID NOT PROVIDE THIS INFORMATION OR RETURN THE CABLE AND CONNECTOR. THEREFORE, THE MISONIX INC. INVESTIGATION IS LIMITED TO ANALYZING THE PHOTOGRAPHS PROVIDED BY THE HOSPITAL, CONDUCTING TREND ANALYSIS AND IDENTIFYING POTENTIAL ROOT CAUSES FOR THE EVENT. TREND ANALYSIS: MISONIX HAS INTRODUCED (B)(4) DISPOSABLE STERILE MONOPOLAR CABLES (CFSM6-D050) INTO COMMERCE FROM THE DATE THE PRODUCT WAS INTRODUCED INTO THE (B)(6) (FROM (B)(6) 2013 THROUGH (B)(6) 2017). THERE WERE NO OTHER COMPLAINTS OR ADVERSE EVENTS REPORTED TO MISONIX INC. ON THE CABLE. GLOBALLY, EXCLUDING THE PRC SALES, (B)(4) DISPOSABLE STERILE MONOPOLAR CABLES WERE INTRODUCED INTO COMMERCE FOR THAT TIME PERIOD. THERE WERE NO OTHER COMPLAINTS OR ADVERSE EVENTS REPORTED TO MISONIX INC. ON THE CABLE. THE RESULTS ARE SUMMARIZED IN THE TABLE BELOW. (B)(4). THE CURRENT ROUTINE MISONIX INC. GLOBAL TREND ANALYSIS REPORT COVERS A PERIOD OF THE TWO MOST RECENT YEARS. THE TREND ANALYSIS REPORT FOR MONOPOLAR CABLE AND CONNECTORS FROM (B)(6) 2015 UNTIL (B)(6) 2017 INDICATES THIS IS THE FIRST COMPLAINT RECEIVED ON THESE PARTS. THE QUANTITY OF PRODUCT INTRODUCED INTO COMMERCE IN THE (B)(6) AND GLOBALLY IS INDICATED IN THE CHART BELOW. (B)(4). THE SUBJECT COMPLAINT INVESTIGATION - CONNECTOR NOT INVOLVED WITH THE ROOT CAUSE. GLOBALLY, FAILURE ANALYSIS: THE COMPLAINT SAMPLE AND INFORMATION ON THE PART NUMBER AND LOT NUMBER WERE NOT RECEIVED FROM THE HOSPITAL. THEREFORE, FAILURE ANALYSIS IS BASED ON THE PHOTOGRAPHS PROVIDED. THE PHOTOGRAPHS SHOW THE CFSM6-D050 CABLE JACKET AND MALE PIN SLEEVE ARE MELTED WITH BLACK CHARRING. THE MELTING AND CHARRING IS MOST PREVALENT AT THE WIRE JACKET INSULATION/MALE PIN TERMINAL SLEEVE INTERFACE. THE CFSM4-M100 CONNECTOR IS MELTED AT THE FEMALE CONNECTION END. THE END ACCEPTS THE MALE PIN FROM THE CABLE. THE CONNECTOR DOES NOT APPEAR TO BE INVOLVED IN THE PRIMARY EVENT. THE PRIMARY EVENT APPEARS TO HAVE OCCURRED AT THE WIRE JACKET INSULATION/MALE PIN TERMINAL SLEEVE INTERFACE. THE CONNECTOR APPEARS TO BE MELTED AND CHARRED BECAUSE OF THE PRIMARY EVENT. IT IS NOTED THAT A PIECE OF YELLOW TAPE IS ATTACHED TO THE CABLE AT THE WIRE JACKET INSULATION/MALE TERMINAL SLEEVE INTERFACE. THE TAPE IS ATTACHED TO THE MALE TERMINAL SLEEVE AND IS INTIMATE WITH THE BURNED AREA. THERE ARE THREE POTENTIAL ROOT CAUSES LISTED IN ORDER OF PROBABILITY AS FOLLOWS: I. THE YELLOW TAPE INDICATES THE CABLE WAS DAMAGED AND THAT A REPAIR WAS ATTEMPTED BY USING THE TAPE. THE REPAIR WAS PROBABLY INADEQUATE. THE MONOPOLAR CABLE IS A SINGLE CONDUCTOR CABLE WITHOUT A GROUNDED SHIELD. IF THERE WAS A BREECH IN THE INSULATION THIS WOULD CAUSE AN INTERMITTENT OPEN CIRCUIT, POTENTIALLY CAUSING AN ARC CAUSING HEAT TO BURN, CHAR AND MELT THE INSULATION AT THE HIGH CURRENT AND VOLTAGE GENERATED BY THE ELECTROCAUTERY GENERATOR. THE MISONIX INC. IFU MANUAL, SECTION 12.2 REPAIR, SERVICE AND REPLACEMENT PARTS STATES THAT ALL REQUESTS FOR REPAIRS AND REPLACEMENT PARTS SHOULD BE DIRECTED TO MISONIX OR AN AUTHORIZED MISONIX REPRESENTATIVE. ALWAYS PROVIDE MODEL AND SERIAL NUMBER OF MALFUNCTIONING ITEMS. ONLY PERSONS AUTHORIZED BY MISONIX INC. AND QUALIFIED BY EDUCATION AND EXPERIENCE IN ELECTRICAL TEST METHODS CAN PERFORM REPAIRS TO THE SONASTAR UNIT. THE YELLOW TAPE INDICATES THERE WAS AN UNAUTHORIZED REPAIR. II. WHILE THE PRODUCT IS LABELED STERILE, SINGLE USE, THE CABLE WAS CLEANED, STERILIZED AND REUSED. REPETITIVE USE, CLEANING AND STERILIZATION CAUSED THE CABLE INSULATION TO BREAK. THE USER ATTEMPTED TO REPAIR THE BREAK WITH YELLOW TAPE. REFER TO POTENTIAL ROOT CAUSE (I) ABOVE. THE MISONIX IFU MANUAL CONTAINS THE FOLLOWING CAUTION AND NOTE: CAUTION 6.7: IF COAG IS TO BE PERFORMED, THE SINGLE-USE MONOPOLAR HANDPIECE CABLE MUST BE INTRODUCED IN THE STERILE FIELD, BECAUSE THE CABLE IS SUPPLIED STERILE, AND IS NOT AUTOCLAVABLE. DO NOT RE-STERILIZE THE SINGLE-USE MONOPOLAR HANDPIECE CABLE. NOTE 7.2 MONOPOLAR HANDPIECE CABLE IS SUPPLIED STERILE AND IS NOT STERILIZABLE. III. THE CFSM6-D050 CABLE PIN WAS NOT CONNECTED TO THE CFSM4-M100 FEMALE CONNECTOR COMPLETELY BY THE SCRUB NURSE. THIS CAUSED AN OPEN CIRCUIT. THE OPEN CIRCUIT CAUSED AN ARC. THE ARC CAUSED HEAT TO BURN, CHAR AND MELT THE INSULATION AT THE HIGH CURRENT AND VOLTAGE GENERATED BY THE ELECTROCAUTERY GENERATOR. MISONIX WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER AND HOSPITAL. 4. CONCLUSION: MISONIX DID NOT RECEIVE THE COMPLAINT SAMPLE. MISONIX PERFORMED THE ANALYSIS FROM PHOTOGRAPHS PROVIDED BY THE REPORTER IN THE INITIAL REPORT. THE HOSPITAL DID NOT PROVIDE INFORMATION TO MISONIX ON THE COMPLAINT, INCLUDING THE LOT NUMBER. THE MONOPOLAR CABLE APPEARED TO BE REPAIRED BY THE CUSTOMER WITH YELLOW TAPE, CAUSING A BREECH IN THE INSULATION, RESULTING IN AN ARC CAUSING THE "NAKED FLAME" RESULTING IN MELTING AND CHARRING OF THE INSULATION. THE IFU PROVIDES INFORMATION TO THE USER THAT ALL REPAIRS MUST BE MADE BY MISONIX AND PROVIDES CONTACT INFORMATION TO THE USER TO EFFECT REPAIRS. THEREFORE THE DEVICE WAS MODIFIED (REPAIRED) INCORRECTLY AND THE USER DID NOT FOLLOW INSTRUCTIONS FOR USE TO ONLY HAVE REPAIRS PERFORMED BY MISONIX OR AUTHORIZED SERVICE CENTERS. THE CABLE IS PROMINENTLY LABELED AS SINGLE USE. THE FACT THAT THE CABLE WAS REPAIRED BY THE USER INDICATES REPEATED USE WITH ASSUMED CLEANING AND RE-STERILIZATION. REUSE IS OFF LABEL USE. CLEANING AND RE-STERILIZATION IS OFF LABEL USE. THE USER DID NOT FOLLOW THE LABELED INSTRUCTIONS FOR USE (SINGLE USE) AND WARNINGS TO NOT REUSE SINGLE USE ACCESSORIES. THIS IS THE FIRST EVENT OF THIS NATURE REPORTED TO MISONIX SINCE THE PRODUCT INTRODUCTION INTO THE PRC. THE COMPLAINT RATE IS (B)(4) BASED ON UNITS SOLD GLOBALLY. NO FURTHER ACTION IS WARRANTED. MISONIX WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER AND HOSPITAL.
A REPORT WAS RECEIVED FROM (B)(6), THE PRC DISTRIBUTOR AND LEGAL AGENT FOR MISONIX INC. THAT IS NO LONGER UNDER CONTRACT WITH MISONIX, INC. NO PATIENT OR USER INJURY WAS REPORTED. A MALFUNCTION WITH THE MONOPOLAR COAGULATION SYSTEM WIRE AND CONNECTOR WAS REPORTED. THE VERBATIM REPORT FOLLOWS: (B)(6) VERY RECENTLY RECEIVED A MALFUNCTION REPORT FROM (B)(6) HOSPITAL: WHEN USING COAG FUNCTION WITH VALLEY LAB FX, AFTER THE FOOTSWITCH WAS PRESSED, NAKED FLAME WAS FOUND AT THE CONNECTION PART BETWEEN SONASTAR AND VALLEY LAB FX , AND THE CABLE WAS BURNED AS CONFIRMED BY THE PHOTOS. THEN HEAD NURSE TURNED OFF THE SYSTEM, CHECKED BOTH SONASTAR AND RF GENERATOR, BUT FOUND THE TWO MACHINES WERE CONNECTED PROPERLY, BOTH MACHINES WERE FUNCTIONAL AND WORKED WELL. NOW THE HOSPITAL IS CONSIDERING REPORTING THIS TO (B)(6) AS AN ADVERSE EVENT. PLEASE MAKE SURE TO CONTACT THE HOSPITAL AS SOON AS POSSIBLE ABOUT THIS SITUATION, THE CONTACT PERSON AT THE HOSPITAL IS (B)(6). THE EVENT OCCURRED IN THE (B)(6). THE DATE OF THE EVENT WAS NOT REPORTED. THE PATIENT INFORMATION WAS NOT REPORTED. THE CLINICAL PROCEDURE AND PATIENT HISTORY WAS NOT REPORTED. A MALFUNCTION WAS REPORTED - BURNT MONOPOLAR CABLE. NO DEATH OR INJURY WAS REPORTED. THE PRODUCT SUBJECT OF THIS REPORT IS THE MISONIX SONASTAR ULTRASONIC SURGICAL ASPIRATOR MONOPOLAR RF CABLE ((B)(4)) FOR ELECTROCAUTERY AND THE MISONIX SONASTAR ULTRASONIC SURGICAL ASPIRATOR MONOPOLAR RF CABLE CONNECTOR ((B)(4)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630313 | SONASTAR ULTRASONIC SURGICAL ASPIRATOR MONOPOLAR RF CABLE | RF CABLE ACCESSORY FOR AN ULTRASONIC SURGICAL INSTRUMENT. | LFL | MISONIX INC. | CFSM6-D050 | 00841626100572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |