BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH-BLADE CLICKFIT REUSE HAND 5MM45CM

    MDR report key: 5704013 · Received June 7, 2016

    Report

    Report Number
    1038548-2016-00082
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 20, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    PMA / PMN Number
    K030890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS INVESTIGATION IS A CONTINUATION: ATTEMPTS TO RECREATE THE FAILURE. PREVIOUSLY IN SIMILAR COMPLAINT, (B)(4) MANUFACTURING ENGINEER TRIED TO RECREATE THIS TYPE OF FAILURE BY STRESSING THE UNIT IN THREE DIFFERENT WAYS; USE OF EXCESSIVE LIQUID COUPLED WITH HIGH ELECTRICITY, REPEATED HIGH ELECTRICITY, LIQUID WITH A MISASSEMBLED SCISSOR TIP, AND LASTLY THE APPLICATION OF EXCESSIVE HEAT BEING APPLIED TO HALAR. ALL ATTEMPTS TO RECREATE THE FAILURE FAILED. A SP90-1053 SWITCH-BLADE CLICKFIT 3.0 REUSABLE HANDLE DEVICE AND A STERILE DISPOSABLE SCISSOR TIP (PART NUMBER 89-5103) WERE ASSEMBLED. THE TUBE AND SCISSOR TIP WERE SOAKED WITH SALINE ENSURING ALL CONNECTIONS WERE WET. THEN THE INSULATION WAS CHALLENGED TO THE EXTREME BY PERFORMING HYPOT TESTING AT 3.0KV WHICH IS ABOVE THE 0.5KVP MAXIMUM RATING SPECIFIED FOR THE DEVICE PER IFU 26-0065 REV J. THE DEVICE DID NOT BLOWOUT OR DAMAGE THE INSULATION AS OBSERVED WITH THE COMPLAINT SAMPLE; THE 89-5103 SCISSOR TIP WAS CONNECTED TO THE SP90-1053 DEVICE LOOSELY TO ALLOW THE SALINE TO SOAK IN THE CONNECTIONS PARTS TO SIMULATE POOLING OF BODILY FLUIDS AND A POOR CONNECTION AT THE TIP. THE SCISSOR TIP WAS PROPERLY AND IMPROPERLY CONNECTED TO THE HANDLE AND HYPOT TESTED AT 3.0KV. WITH THE MOISTURE, A SPARK WAS CREATED IN WHICH THE ELECTRICAL CURRENT FROM THE TEST APPARATUS TO THE TIP OF THE SCISSOR TIPS COULD BE SEEN. THE INSULATION NEVER BLEW OUT AND STILL DID NOT RESEMBLE THE LARGE FAILURE AREA AS OBSERVED WITH THE COMPLAINT SAMPLE. AFTER SEVERAL TESTS AT THE 3.0KV THE SURFACE OF THE HALAR COATING ACROSS THE SHAFT BEGAN TO DEGRADE. IT EXHIBITED AREAS IN WHICH THE HALAR HAD CHANGED AND HAD A TACKY TEXTURE. ALTHOUGH THE SURFACE HAD CHANGED, THE DIFFERENCE WAS MINIMAL AND THE TUBE STILL PASSED HYPOT TESTING AT THE EXTREME 3.0KV SETTING. DURING THE TESTING IT WAS NOTED THAT THE COMPLAINT FAILURE WAS LOCATED OUTSIDE OF THE AREA WHERE THE INSULATION RESIDES THEREFORE THE FAILURE DIDN¿T OCCUR DUE TO POOLING BETWEEN THE SCISSOR TIPS AND THE TUBE; TO SIMULATE THE INSULATION BEING EXPOSED TO EXTREME HEAT FROM CROSSING WITH ANOTHER ELECTROSURGICAL INSTRUMENT AND SEE IF THE HALAR WOULD MELT IN A SIMILAR MANNER AS THE COMPLAINT SAMPLE, (B)(4) SUBJECTED A COATED TUBE TO A BLOW TORCH AND BURNT THE SURFACE. ALSO, A PIECE OF METAL WAS HEATED AND PLACED ON THE TUBE SURFACE. THE FAILED INSULATION STILL DID NOT RESEMBLE THE COMPLAINT SAMPLE. THE IFU, 26-0065 REV K, CONTAINS SUFFICIENT INFORMATION TO PROVIDE GUIDANCE FOR USE TO THE END USER. SOME CAUTIONS AND WARNINGS ARE LISTED BELOW. ¿THE SNOWDEN PENCER INSTRUMENT IS A MONOPOLAR DEVICE AND SHOULD ONLY BE CONNECTED TO A GENERATOR THAT IS COMPATIBLE WITH MONOPOLAR DEVICES. IT IS RECOMMENDED THAT THE DEVICE IS USED WITH AN HF GENERATOR THAT CONTAINS CONTACT QUALITY MONITORING (RETURN ELECTRODE MONITORING) WITH A SIGNAL TO INDICATE THERE IS CONTACT TO THE PATIENT¿; ¿DO NOT EXCEED THE 0.5KVP MAXIMUM RATING SPECIFIED FOR THIS DEVICE¿; ¿CONDUCTIVE FLUIDS, (E.G., BLOOD OR SALINE) IN DIRECT CONTACT WITH AN ACTIVE ELECTRODE MAY CARRY ELECTRICAL CURRENT OR HEAT WHICH MAY CAUSE UNINTENDED BURNS TO THE PATIENT¿; ¿THERE IS A RISK OF POOLING OF FLAMMABLE SOLUTIONS UNDER THE PATIENT OR IN BODY DEPRESSIONS SUCH AS UMBILICUS AND IN BODY CAVITIES SUCH AS THE VAGINA. ANY FLUID POOLED IN THESE AREAS SHOULD BE MOPPED UP BEFORE HF SURGICAL EQUIPMENT IS USED¿; ¿DEVICE INCLUDING INSULATION AND DEVICE ACCESSORIES MUST BE INSPECTED PRIOR TO USE TO ENSURE INTEGRITY. TO PREVENT THE POSSIBILITY OF ELECTRICAL SHOCKS OR BURNS, DO NOT USE DEVICES WITH BREAKS IN THE INSULATION¿; ALWAYS USE CAUTION WHEN INSERTING OR REMOVING DEVICES THROUGH CANNULA. LATERAL PRESSURE ON THE DEVICE DURING REMOVAL CAN DAMAGE THE WORKING TIP, SHAFT OF THE DEVICE AND OR INSULATION. (B)(4) WAS UNABLE TO RECREATE THE FAILURE AS WELL AS DETERMINE AN EXACT ROOT CAUSE TO THE FAILURE WHILE CREATING TYPICAL AND MISUSE SITUATIONS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES. THE ROOT CAUSE COULD NOT BE DETERMINED THROUGH THE INVESTIGATION. THE DEVICE IS 4 YEARS OLD AND HAD NEVER BEEN REPAIRED BY (B)(4). THESE DEVICES ARE REUSABLE AND ARE REPROCESSED FREQUENTLY; THEREFORE, IT IS INHERENT THAT OVER TIME DAMAGE CAN OCCUR DURING HANDLING AND THEREFORE THE PRODUCT IS TO BE INSPECTED PRIOR TO EACH USE PER IFU 26-0065 REV K. THE CUSTOMER STATED THE SURGICAL TECH VISUALLY EXAMINES THE INSTRUMENT FOR ANY DAMAGE OR DEFECT EVERY CASE, PRIOR TO USE ON A PATIENT AND THEY HAVE BEEN TOLD THAT CS ALSO USES ELECTRICAL TESTING. ¿. BASED ON WHAT THE CUSTOMER STATED (B)(4) WAS UNABLE TO EXACTLY DETERMINE IF THE CUSTOMER¿S VISUAL INSPECTION WAS SUFFICIENT ENOUGH TO CHECK THE INTEGRITY OF THE INSULATION OR IF THE COMPLAINT SAMPLE WAS POSITIVELY ELECTRICALLY TESTED PRIOR TO USE. IN ADDITION, (B)(4) IS UNABLE TO DETERMINE IF THE COMPLAINT DEVICE WAS ACTIVATED OR NOT; THEREFORE, THERE IS A POSSIBILITY THAT THE RETURNED INSTRUMENT WAS STILL CHARGED WHEN IT WAS REMOVED FROM THE METAL ROBOTIC CANNULA. BASED ON THIS NEW INFORMATION, THE DEVICE COULD HAVE BRUSHED AGAINST THE SIDES OF THE METAL ROBOTIC CANNULA UPON REMOVAL ARCED / SPARKED AND CAUSED THE BURN TO THE PATIENT. THIS TYPE OF SITUATION COULD CREATE A REACTION WHERE THE INSULATION BLEW OUT FROM THE OUTSIDE IN. AS THERE WAS NO TREND DETECTED FOR THIS FAILURE AND THERE WAS NO ROOT-CAUSE IDENTIFIED, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. THE CUSTOMER WILL BE NOTIFIED THROUGH THE CLOSURE LETTER AND RECOMMENDED TO REVIEW PRODUCT INFORMATION IFU 26-0065-K IN PARTICULAR THE WARNINGS AND THE CAUTION STATEMENTS. (B)(4) WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4):ONE (1) SP90-1253 SWITCH-BLADE CLICKFIT REUSABLE HANDLE DEVICE WAS RETURNED FOR EVALUATION FOR A PATIENT BURN. ALSO RETURNED WAS A SWITCHBLADE SCISSOR TIP THAT IS COMPATIBLE WITH THE RETURNED SP90-1253 HANDLE DEVICE. ACCORDING TO OUR RECORDS THE DEVICE WAS 4 YEARS OLD AND HAD NEVER BEEN REPAIRED BY BD BEFORE. VISUAL EXAMINATION BY THE QUALITY ENGINEER, QUALITY MANAGER, PRODUCT ENGINEER AND MANUFACTURING ENGINEER CONFIRMED THE REPORTED ISSUE. VISUAL OBSERVATIONS REVEALED THAT THE DAMAGE TO THE INSULATION OCCURRED APPROXIMATELY ½ INCH FROM THE DISTAL END WHERE THE DISPOSABLE TIP WOULD BE CONNECTED TO THE DEVICE. THE DAMAGE WAS A LARGE CHUNK OF INSULATION MISSING SPANNING APPROXIMATELY ¼ INCH WIDE. THE COMPLAINT SAMPLE WAS HYPOT TESTED AND FAILED HYPOT TEST FURTHER CONFIRMING THE FAILURE. IT WAS DETERMINED BY THE APPEARANCE OF THE SURFACE OF THE CHARRED INSULATION BREAK THE INSULATION HAD BLOWN OUT FROM THE OUTSIDE IN FROM AN UNKNOWN SOURCE. REVIEW OF CUSTOMER INSPECTION METHOD IT WAS REPORTED THAT ¿IN THE OR, THE SURGICAL TECH VISUALLY EXAMINES THE INSTRUMENT FOR ANY DAMAGE OR DEFECT EVERY CASE, PRIOR TO USE ON A PATIENT.¿ ¿WE'VE BEEN TOLD THAT CS ALSO USES ELECTRICAL TESTING¿. BASED ON WHAT THE CUSTOMER STATED BD WAS UNABLE TO EXACTLY DETERMINE IF THE CUSTOMER¿S VISUAL INSPECTION WAS SUFFICIENT ENOUGH TO CHECK THE INTEGRITY OF THE INSULATION OR IF THE COMPLAINT SAMPLE WAS POSITIVELY ELECTRICALLY TESTED PRIOR TO USE. INCORRECT QUALITY INSPECTION COULD POTENTIALLY DEEM AN UNACCEPTABLE PRODUCT TO BE DEEMED ACCEPTABLE. REVIEW OF THE SURGICAL FIELD ON (B)(6) 2016, THE CUSTOMER REPORTED THEY WERE USING ERBE GENERATOR, SPECIFICALLY DESIGNED FOR USE WITH THE DA VINCI XI ROBOTIC SYSTEM. SETTINGS WERE AT 4 CUT & 4 COAG. AFTER REVIEWING THE CASE WITH THE SURGICAL ASSIST, THE ONLY OTHER INSTRUMENT BESIDES THE SNOWDEN SCISSORS, WAS THE 8MM ROBOTIC SCOPE AND METAL ROBOTIC CANNULA. FROM THE INFORMATION PROVIDED BD IS UNABLE TO DETERMINE IF THE COMPLAINT DEVICE WAS ACTIVATED OR NOT; THEREFORE, THERE IS A POSSIBILITY THAT THE RETURNED INSTRUMENT WAS STILL CHARGED WHEN IT WAS REMOVED FROM THE METAL ROBOTIC CANNULA. BASED ON THIS NEW INFORMATION, THE DEVICE COULD HAVE BRUSHED AGAINST THE SIDES OF THE METAL ROBOTIC CANNULA UPON REMOVAL AND ARCED / SPARKED AND BURNED THE PATIENT. THIS TYPE OF SITUATION COULD CREATE A REACTION WHERE THE INSULATION BLEW OUT FROM THE OUTSIDE IN. REVIEW OF MATERIALS/PROCESSING A SIMILAR COMPLAINT WAS FILED IN 2014 AND THE SUPPLIER OF THE INSULATION TO THE TUBE REVIEWED THIS TYPE OF FAILURE AND REPORTED THAT THEY HAD NEVER SEEN A FULL BLOW OUT LIKE THE ONE WITNESSED IN THIS COMPLAINT. IT WAS NOTED THAT IF THERE WAS A BUBBLE IN THE COATING, IT CAN CAUSE A SMALL HOLE ALL THE WAY TO THE METAL OF THE TUBE DURING HYPOT, HOWEVER THE SIZE WOULD BE ABOUT THE SIZE OF A PINHOLE AND NOTHING LIKE THE COMPLAINT SAMPLE. DESIGN ASSURANCE REVIEWED THIS TYPE OF FAILURE BACK IN 2014 AND NOTED THAT THIS TYPE OF EXTREME BLOW OUT OF THE INSULATION HAD NEVER BEEN SEEN. THREE POTENTIAL ROOT CAUSES WERE HYPOTHESIZED BY DESIGN ASSURANCE. ¿ THE DAMAGE COULD POSSIBLY BE DUE TO ANOTHER UNKNOWN CROSSED INSTRUMENT DURING THE PROCEDURE. ¿ EXCESSIVE LIQUID IN THE SURGICAL FIELD, COUPLED WITH INSTRUMENTS BEING CROSSED, COULD POTENTIALLY CAUSE A BLOWOUT OF THE INSULATION. ¿ IT COULD ALSO BE THE CONNECTION BETWEEN THE END OF THE TIP INSULATION AND THE COATED INSULATION. NOTE: THE SCISSOR TIP PRODUCT RETURNED WAS VISUALLY INSPECTED AND CHECKED FOR FUNCTIONALITY AND WAS FUNCTIONING AS INTENDED. THIS INVESTIGATION WILL BE CONTINUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PHYSICIAN WAS USING THE LAP SCISSORS AND A PATIENT WAS BURNED DURING A ROBOT LAPAROSCOPY WHICH WAS COMPLETED AS PLANNED. THE MD WAS TAKING DOWN ADHESIONS, WHEN INSTRUMENT WAS PASSED BACK TO TECH AN AREA ON THE SHAFT APPEARED MELTED. CAMERA WAS USED AND DISCOVERED AREA OF INJURY TO PATIENT. A CHAR MARK WAS NOTICED ON THE PATIENT'S ANTERIOR PERITONEUM. THE SITE WAS EXCISED AND SENT TO PATHOLOGY. THE PATIENT'S HUSBAND WAS ALSO NOTIFIED. NO ADDITIONAL EVENT INFORMATION RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 01AUG2016: WHAT KIND OF GENERATOR WAS USED AND WHAT VOLTAGE SETTINGS WHERE USED? - ERBE GENERATOR, SPECIFICALLY DESIGNED FOR USE WITH THE DA VINCI XI ROBOTIC SYSTEM. SETTINGS WERE AT 4 CUT & 4 COAG. THESE SUGGESTIONS WERE GIVEN BY OUR EXPERIENCED INTUITIVE REP IN THE ROOM. WAS THERE ANOTHER INSTRUMENT INVOLVED IN THE SURGICAL FIELD WHEN THE DEVICE ARCED? AFTER REVIEWING THE CASE WITH THE SURGICAL ASSIST, THE ONLY OTHER INSTRUMENT BESIDES THE SNOWDEN SCISSORS, WAS THE 8MM ROBOTIC SCOPE AND METAL ROBOTIC CANNULAE. WHAT IS THE CUSTOMERS METHOD FOR INSPECTING THE INSULATION PRIOR TO USE? IN THE OR, THE SURGICAL TECH VISUALLY EXAMINES THE INSTRUMENT FOR ANY DAMAGE OR DEFECT EVERY CASE, PRIOR TO USE ON A PATIENT. WE'VE BEEN TOLD THAT CS ALSO USES ELECTRICAL TESTING, HOWEVER, ANY FURTHER QUESTIONS/DETAILS REGARDING THE TESTING DONE IN CS WOULD BE BETTER ANSWERED AND SHOULD BE DIRECTED TO DAVE JACKSON, MANAGER OF CS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359500 SWITCH-BLADE CLICKFIT REUSE HAND 5MM45CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC SP90-1253 849479 J12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other