BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO RF 90° MULTIPORT

    MDR report key: 6266017 · Received January 20, 2017

    Report

    Report Number
    1220246-2016-00611
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    December 27, 2016
    Report Date
    January 20, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    UDI-DI
    00888867248243
    PMA / PMN Number
    K161581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, 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 TO CORRECT COMMON DEVICE NAME AND PRODUCT CODE. NO PROBLEMS FOUND DURING THE EVALUATION OF THE DEVICE. DEVICE WAS VISUALLY INTACT AND APPEARED NORMAL WITH APPROXIMATELY 5 MINUTES OF USE. DEVICE WAS TESTED AND INSPECTED TO SPECIFICATIONS. NO ERROR CODES WERE PRESENT IN PROBE MEMORY. THE RETURNED PROBE WAS ACTIVATED WITH SUCTION APPLIED USING THE RETURNED CONSOLE. A NEW PROBE FROM A DIFFERENT LOT WAS TESTED IN THE SAME MANNER, ALSO WITH THE RETURNED CONSOLE. NO DIFFERENCES IN PERFORMANCE WERE OBSERVED. UPON DISASSEMBLY, THERE WERE NO UNUSUAL OBSERVATIONS INTERNAL TO THE DEVICE. 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 (DATE OF BIRTH, 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 PROBLEMS FOUND DURING THE EVALUATION OF THE DEVICE. DEVICE WAS VISUALLY INTACT AND APPEARED NORMAL WITH APPROXIMATELY 5 MINUTES OF USE. DEVICE WAS TESTED AND INSPECTED TO SPECIFICATIONS. NO ERROR CODES WERE PRESENT IN PROBE MEMORY. THE RETURNED PROBE WAS ACTIVATED WITH SUCTION APPLIED USING THE RETURNED CONSOLE. A NEW PROBE FROM A DIFFERENT LOT WAS TESTED IN THE SAME MANNER, ALSO WITH THE RETURNED CONSOLE. NO DIFFERENCES IN PERFORMANCE WERE OBSERVED. UPON DISASSEMBLY, THERE WERE NO UNUSUAL OBSERVATIONS INTERNAL TO THE DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SHOULDER ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON WAS USING AN AR-9811, 90° MULTIPORT APOLLO ASPIRATING ABLATOR (LOT: S160346 LINE 179007). THE SETTINGS WERE SET TO 9 ABLATE, 2 COAG. THE WAND HAD BEEN IN USE APPROXIMATELY 5 MINUTES AND THE SURGEON WAS IN THE SUB-ACROMIAL SPACE. IT WAS FOUND BY THE NURSE ANESTHESIOLOGIST THAT EVERY TIME THE WAND WAS ON AND TOUCHING THE PATIENT'S TISSUE, THE PATIENT'S PULSE WOULD DROP. THE NURSE ANESTHESIOLOGIST VERIFIED THIS BY WATCHING THE EKG MACHINE ALONG WITH MANUALLY TAKING A PULSE. PER THE ANESTHESIOLOGIST, THE PATIENT SUFFERED A RAPID SVT OR VT LASTING ABOUT 15 SECONDS (RATE+150-200). IT WAS NOT A PULSELESS EVENT AND THE PATIENT WAS NOT HEMODYNAMICALLY UNSTABLE. IT APPEARED AS IF THE ELECTRICAL CURRENT FROM THE WAND EFFECTIVELY SHOCKED THE PATIENT'S MYOCARDIUM. OF NOTE, THE PATIENT'S DELTOID AND BICEPS WERE CONTRACTING VIGOROUSLY DURING USE OF THE WAND AS WELL. IT WAS REPORTED THE PATIENT WAS OTHERWISE HEALTHY. THE SURGEON STOPPED USE OF THE APOLLO IMMEDIATELY AND SWITCHED TO A DIFFERENT MANUFACTURER'S CONSOLE AND WAND. HE WAS ABLE TO FINISH THE CASE WITHOUT FURTHER INCIDENT. PATIENT IS A (B)(6) MALE WITH AN AVERAGE BUILD. SALES REP WAS PRESENT IN THE CASE. THE APOLLO SYSTEM HAD BEEN USED ON AN EARLIER PATIENT THAT DAY, IN THE SAME ROOM WITH THE SAME SET UP, WITH NO INCIDENTS OCCURRING WITH THE FIRST PATIENT'S SURGERY. THE PROBE WAS USED APPROXIMATELY 5 MINUTES IN THE FIRST CASE AND WAS DISCARDED. THE APOLLO WAS NOT BEING USED AS A STAND ALONE, BUT AS PART OF A STACK. DURING THIS PROCEDURE THE APOLLO CABLE WAS DRAPED ACROSS THE PATIENT'S LOWER TORSO. RF WAS ISOLATED OUTSIDE THAT BUNDLE. PATIENT WAS IN LEFT LATERAL DECUBITUS POSITION. THE DEVICE WAS BEING USED THROUGH THE LATERAL PORTAL ONLY. PATIENT HAD NO PACEMAKER OR STENTS. THE OTHER MANUFACTURER'S DEVICE WAS PLUGGED INTO THE SAME OUTLET AS THE APOLLO CONSOLE. THE OTHER MANUFACTURER'S DEVICE WAS DRAPED CLOSE TO THE SAME AS THE APOLLO HAD BEEN. MORE IN LINE WITH THE OTHER CORDS BUT NOT PART OF THE BUNDLE. DURING THE CASE USE OF THE APOLLO THERE WAS SLIGHT INTERFERENCE ON THE EKG MONITOR AND SLIGHTLY LESS INTERFERENCE WHEN USING THE OTHER MANUFACTURER'S PRODUCT. SETTING ON THE APOLLO AND THE OTHER MANUFACTURER'S PRODUCT WERE THE SAME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SHOULDER ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON WAS USING AN AR-9811, 90° MULTIPORT APOLLO ASPIRATING ABLATOR (LOT: S160346 LINE 179007). THE SETTINGS WERE SET TO 9 ABLATE, 2 COAG. THE WAND HAD BEEN IN USE APPROXIMATELY 5 MINUTES AND THE SURGEON WAS IN THE SUB-ACROMIAL SPACE. IT WAS FOUND BY THE NURSE ANESTHESIOLOGIST THAT EVERY TIME THE WAND WAS ON AND TOUCHING THE PATIENT'S TISSUE, THE PATIENT'S PULSE WOULD DROP. THE NURSE ANESTHESIOLOGIST VERIFIED THIS BY WATCHING THE EKG MACHINE ALONG WITH MANUALLY TAKING A PULSE. PER THE ANESTHESIOLOGIST, THE PATIENT SUFFERED A RAPID SVT OR VT LASTING ABOUT 15 SECONDS (RATE+150-200). IT WAS NOT A PULSELESS EVENT AND THE PATIENT WAS NOT HEMODYNAMICALLY UNSTABLE. IT APPEARED AS IF THE ELECTRICAL CURRENT FROM THE WAND EFFECTIVELY SHOCKED THE PATIENT'S MYOCARDIUM. OF NOTE, THE PATIENT'S DELTOID AND BICEPS WERE CONTRACTING VIGOROUSLY DURING USE OF THE WAND AS WELL. IT WAS REPORTED THE PATIENT WAS OTHERWISE HEALTHY. THE SURGEON STOPPED USE OF THE APOLLO IMMEDIATELY AND SWITCHED TO A DIFFERENT MANUFACTURER'S CONSOLE AND WAND. HE WAS ABLE TO FINISH THE CASE WITHOUT FURTHER INCIDENT. PATIENT IS A (B)(6)MALE WITH AN AVERAGE BUILD. SALES REP WAS PRESENT IN THE CASE. THE APOLLO SYSTEM HAD BEEN USED ON AN EARLIER PATIENT THAT DAY, IN THE SAME ROOM WITH THE SAME SET UP, WITH NO INCIDENTS OCCURRING WITH THE FIRST PATIENT'S SURGERY. THE PROBE WAS USED APPROXIMATELY 5 MINUTES IN THE FIRST CASE AND WAS DISCARDED. THE APOLLO WAS NOT BEING USED AS A STAND ALONE, BUT AS PART OF A STACK. DURING THIS PROCEDURE THE APOLLO CABLE WAS DRAPED ACROSS THE PATIENT'S LOWER TORSO. RF WAS ISOLATED OUTSIDE THAT BUNDLE. PATIENT WAS IN LEFT LATERAL DECUBITUS POSITION. THE DEVICE WAS BEING USED THROUGH THE LATERAL PORTAL ONLY. PATIENT HAD NO PACEMAKER OR STENTS. THE OTHER MANUFACTURER'S DEVICE WAS PLUGGED INTO THE SAME OUTLET AS THE APOLLO CONSOLE. THE OTHER MANUFACTURER'S DEVICE WAS DRAPED CLOSE TO THE SAME AS THE APOLLO HAD BEEN. MORE IN LINE WITH THE OTHER CORDS BUT NOT PART OF THE BUNDLE. DURING THE CASE USE OF THE APOLLO THERE WAS SLIGHT INTERFERENCE ON THE EKG MONITOR AND SLIGHTLY LESS INTERFERENCE WHEN USING THE OTHER MANUFACTURER'S PRODUCT. SETTING ON THE APOLLO AND THE OTHER MANUFACTURER'S PRODUCT WERE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51065 APOLLO RF 90° MULTIPORT ELECTROSURGICAL CUTTING AND COAGULATION & ACCESSORIES GEI ARTHREX, INC. S160346 00888867248243

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other AR-9800 SERIAL NUMBER (B)(4) SYNERGY RF CONSOLE| AR-9800-F LOT 50393099 SYNERGY RF FOOTSWITCH