BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM IQ APEX KNIFE

    MDR report key: 16794442 · Received April 24, 2023

    Report

    Report Number
    3015967359-2023-00777
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    December 30, 2022
    Report Date
    June 1, 2023
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    UDI-DI
    37613327422499
    PMA / PMN Number
    K213824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A FOLLOW-UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    H6: THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SONOPET IQ TIP GOT HOT. THE PATIENT WAS BURNED ON THE FACE. THE BURN WAS LOCATED ON THE UPPER NOSE OF THE PATIENT. IT WAS APPROX 1CM IN SIZE. THE DOCTOR MENTIONED HE MAY TRY TO DO "PRP THEREAPY WITH MICRO NEEDLING". NO INFECTION WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR TIP 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SONOPET IQ TIP GOT HOT. THE PATIENT WAS BURNED ON THE FACE. THE BURN WAS LOCATED ON THE UPPER NOSE OF THE PATIENT. IT WAS APPROX 1CM IN SIZE. THE DOCTOR MENTIONED HE MAY TRY TO DO "PRP THEREAPY WITH MICRO NEEDLING". NO INFECTION WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR TIP 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782646 11CM IQ APEX KNIFE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN 37613327422499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown