BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO RF® H50, ASPIRATING, ABLATOR, 50°

    MDR report key: 16427609 · Received February 23, 2023

    Report

    Report Number
    1220246-2023-06334
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 27, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    UDI-DI
    00888867142473
    PMA / PMN Number
    K161581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. VISUAL EVALUATION FOUND THAT THE ASPIRATING PROBE ELECTRODE FACE AND CERAMIC END WERE BROKEN OFF AND NOT RETURNED. THE MOST LIKELY CAUSE IS ATTRIBUTED TO AN IMPACT WITH ANOTHER DEVICE OR HARD SURFACE DURING USE, CHARACTERIZING MISUSE DUE TO USER ERROR. REFER TO INVESTIGATION PHOTOS.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 20-FEB-2023: FURTHER INFORMATION WAS RECEIVED WITH THE DEVICE. THE TIP IS BROKEN OFF AT THE HIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576849 APOLLO RF® H50, ASPIRATING, ABLATOR, 50° ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHREX, INC. APOLLO RF® H50, ASPIRATING, ABLATOR, 50° 2109134 00888867142473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown