BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO RF 90 DEGREE MULTIPORT

    MDR report key: 6463835 · Received April 6, 2017

    Report

    Report Number
    1220246-2017-00113
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    March 4, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    UDI-DI
    00888867248243
    PMA / PMN Number
    K161581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. NO DEVICE MALFUNCTION IDENTIFIED. AT THIS TIME, IT CANNOT BE DETERMINED HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE SURGEON'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO ARTHREX. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS A FOLLOW-UP SUBMISSION DUE TO DEVICE EVALUATION AND MORE EVENT INFORMATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION DID NOT DETECT ELECTRICAL SHOCK DURING FUNCTIONAL TEST OF DEVICE. HOWEVER, THE EVALUATION REVEALED THAT THE DEVICE'S MEMORY LOG DISPLAYED ERROR 23. ERROR CODE 23 IS A POWER BUTTON STUCK CODE AND WILL CAUSE THE CONSOLE TO ALARM. WHEN THE CONSOLE ALARMS, THE DEVICE IS UNABLE TO BE ACTIVATED. FURTHER EVALUATION OF DEVICE REVEALED SALINE ENTERED FROM THE PROXIMAL END OF THE HANDLE. SALINE INGRESS INTO BUTTON PCB AREA CAUSED SNAP DOME TO REGISTER AS DEPRESSED AND ALARMED WHEN INSERTED INTO THE CONSOLE. AT THIS TIME, THE CAUSE OF THE USER'S EXPERIENCE IS UNDETERMINED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017 THE SURGEON WAS USING THE APOLLORF PROBE AR-9811 LOT NUMBER S160441. AFTER ABOUT 35 MINUTES INTO THE PROCEDURE WITHOUT ACTIVATING THE WAND AND WITHOUT TOUCHING THE CONTROLS ON THE CONSOLE, THE CUT ALARM STARTED TO GO OFF AND AT THE SAME TIME THE PARAMETERS STARTED TO INCREASE. IN ADDITION, AT THAT TIME THE SURGEON STATED THAT HE RECEIVED AN ELECTRICAL SHOCK. THE SURGEON SHUT DOWN THE UNIT AND STARTED THE UNIT BACK UP AND THE SAME EVENT OCCURRED AGAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2017:THE APOLLO AR-9811 WAS CONNECTED WITHIN 20 MINUTES OF THE SURGERY AND USED FOR 40 MINUTES WITHOUT PROBLEMS. WITHIN 60 MINUTES OF SURGERY AND WITHOUT THE DOCTOR ACTIVATING THE TIP OF THE APOLLO AR-9811 THE CONSOLE STARTED SOUNDING AN ALERT AS IF IT WAS BEING USED WITH THE AR-9811. IT RAISED THE CUTOFF PARAMETER TO THE MAXIMUM (9) WITHOUT THE DOCTOR ACTIVATING ANY BUTTONS. AT THIS TIME THE APOLLO WAS POSITIONED ON A SURGICAL TABLE, TABLE WAS COVERED WITH DISPOSABLE CLOTH MARKED (B)(6) MEDICAL DISPOSABLE PRODUCTS. THE SURGEON GRABBED THE AR-9811 BY THE HANDLE WITHOUT PRESSING ANY BUTTONS AND FOR A VERY SHORT TIME FRAME FELT A LIGHT ELECTRICAL SHOCK (NOTHING TO FORCE THE DOCTOR TO RELEASE THE DEVICE). THE SURGEON HAD SURGICAL ASSISTANT TURN OFF THE CONSOLE AND THEN DISCONNECTED THE AR-9811. THE CONSOLE WAS SWITCHED ON AGAIN AND THE AR-9811 WAS RECONNECTED. IT REVERTED AGAIN AND AGAIN TO RAISE THE CUTTING PARAMETERS TO THE MAXIMUM (9) WITHOUT ANYONE PRESSING THE BUTTONS. THE ASSISTANT, WHO HAD TAKEN THE AR-9811 BY ITS PROXIMAL END WITHOUT PUSHING THE BUTTONS, DID NOT SUFFER AN ELECTRICAL SHOCK. THE SURGEON THEN TURNED OFF THE CONSOLE AND REQUESTED THAT THE OPES TIP BE PASSED TO HIM. THE SURGEON WAS USING DOUBLE GLOVES (THE FIRST LAYER WAS HYPOALLERGENIC AND LATEX FREE. THE SECOND LAYER WAS TRADITIONAL SURGICAL GLOVES). SURGEON WAS USING RUBBER SHOES. THE AREA WAS WET WITH RINGER SERUM. THE PROBE WAS NEVER FULLY SUBMERGED IN LIQUID AND IT WAS NOT ALWAYS ON THE SURGICAL FIELD (BOTH THE TIP AND THE CABLE). VIDEO RECORDINGS OF THE CASE WERE TAKEN BUT AVAILABILITY OF REVIEWING THE VIDEO IS UNKNOWN. THE PROCEDURE WAS PERFORMED AT A PRIVATE SURGERY FACILITY THAT SPECIALIZES IN ARTHROSCOPIC SURGERIES. THE DEVICE WAS BEING USED WITH A CENTRAL ASPIRATION PUMP OF THE CLINIC THAT SUCKS UP TO 700MMHG. SURGEON WAS UNWILLING TO BE INTERVIEWED TO CONFIRM WHAT HAPPENED. (HE DOES NOT FEEL IT IS NECESSARY SINCE NEITHER THE SURGEON NOR PATIENT SUFFERED ANY INJURIES).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017 THE SURGEON WAS USING THE APOLLORF PROBE AR-9811 LOT NUMBER S160441. AFTER ABOUT 35 MINUTES INTO THE PROCEDURE WITHOUT ACTIVATING THE WAND AND WITHOUT TOUCHING THE CONTROLS ON THE CONSOLE, THE CUT ALARM STARTED TO GO OFF AND AT THE SAME TIME THE PARAMETERS STARTED TO INCREASE. IN ADDITION, AT THAT TIME THE SURGEON STATED THAT HE RECEIVED AN ELECTRICAL SHOCK. THE SURGEON SHUT DOWN THE UNIT AND STARTED THE UNIT BACK UP AND THE SAME EVENT OCCURRED AGAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. ADDITIONAL INFORMATION RECEIVED 3/30/17: THE APOLLO AR-9811 WAS CONNECTED WITHIN 20 MINUTES OF THE SURGERY AND USED FOR 40 MINUTES WITHOUT PROBLEMS. WITHIN 60 MINUTES OF SURGERY AND WITHOUT THE DOCTOR ACTIVATING THE TIP OF THE APOLLO AR-9811 THE CONSOLE STARTED SOUNDING AN ALERT AS IF IT WAS BEING USED WITH THE AR-9811. IT RAISED THE CUTOFF PARAMETER TO THE MAXIMUM (9) WITHOUT THE DOCTOR ACTIVATING ANY BUTTONS. AT THIS TIME THE APOLLO WAS POSITIONED ON A SURGICAL TABLE, TABLE WAS COVERED WITH DISPOSABLE CLOTH MARKED UNIC MEDICAL DISPOSABLE PRODUCTS. THE SURGEON GRABBED THE AR-9811 BY THE HANDLE WITHOUT PRESSING ANY BUTTONS AND FOR A VERY SHORT TIME FRAME FELT A LIGHT ELECTRICAL SHOCK (NOTHING TO FORCE THE DOCTOR TO RELEASE THE DEVICE). THE SURGEON HAD SURGICAL ASSISTANT TURN OFF THE CONSOLE AND THEN DISCONNECTED THE AR-9811. THE CONSOLE WAS SWITCHED ON AGAIN AND THE AR-9811 WAS RECONNECTED. IT REVERTED AGAIN AND AGAIN TO RAISE THE CUTTING PARAMETERS TO THE MAXIMUM (9) WITHOUT ANYONE PRESSING THE BUTTONS. THE ASSISTANT, WHO HAD TAKEN THE AR-9811 BY ITS PROXIMAL END WITHOUT PUSHING THE BUTTONS, DID NOT SUFFER AN ELECTRICAL SHOCK. THE SURGEON THEN TURNED OFF THE CONSOLE AND REQUESTED THAT THE OPES TIP BE PASSED TO HIM. THE SURGEON WAS USING DOUBLE GLOVES (THE FIRST LAYER WAS HYPOALLERGENIC AND LATEX FREE. THE SECOND LAYER WAS TRADITIONAL SURGICAL GLOVES). SURGEON WAS USING RUBBER SHOES. THE AREA WAS WET WITH RINGER SERUM. THE PROBE WAS NEVER FULLY SUBMERGED IN LIQUID AND IT WAS NOT ALWAYS ON THE SURGICAL FIELD (BOTH THE TIP AND THE CABLE). VIDEO RECORDINGS OF THE CASE WERE TAKEN BUT AVAILABILITY OF REVIEWING THE VIDEO IS UNKNOWN. THE PROCEDURE WAS PERFORMED AT A PRIVATE SURGERY FACILITY THAT SPECIALIZES IN ARTHROSCOPIC SURGERIES. THE DEVICE WAS BEING USED WITH A CENTRAL ASPIRATION PUMP OF THE CLINIC THAT SUCKS UP TO 700MMHG. SURGEON WAS UNWILLING TO BE INTERVIEWED TO CONFIRM WHAT HAPPENED. (HE DOES NOT FEEL IT IS NECESSARY SINCE NEITHER THE SURGEON NOR PATIENT SUFFERED ANY INJURIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246960 APOLLO RF 90 DEGREE MULTIPORT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHREX, INC. S160441 00888867248243

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-9800 SYNERGY RF CONSOLE, SERIAL # (B)(4)