BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM

    MDR report key: 19298517 · Received May 13, 2024

    Report

    Report Number
    0002936485-2024-00378
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    November 15, 2023
    Report Date
    May 13, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327051872
    PMA / PMN Number
    K934094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: PER REP, PRODUCT CAUGHT ON FIRE IN THE OR. REP WOULD LIKE A REPORT BACK TO SEE IF IT WAS ACTUALLY THIS PRODUCT THAT CAUSED IT. UPDATE: QE (B)(4): CALL WITH REP. ACCOUNT IS USING OBSOLETE BOVIE CONSOLES. BOUGHT NEW CONSOLES BUT HAVE NOT USED PROBES WITH NEW CONSOLES. NO PATIENT HARM NO ADVERSE CONSEQUENCES NO MEDICAL INTERVENTION. THE PROBE DID NOT CATCH FIRE IN A PATIENT. CAUTERY WAS NOT BEING ACTIVATED WHEN THIS HAPPENED OUTSIDE OF THE PATIENT. ACCOUNT SAID OUT OF THE CORNER OF THEIR EYE THEY SAW A FLAME. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE 1) CONDUCTIVE IRRIGATING OR ASPIRATING FLUID USED WAS INSIDE THE DISTAL END, AND CONTACTED THE PROBE AND THE SHEATH CAUSING THE SHEATH TO MELT, 2) POWER SET TOO HIGH. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE CAUGHT FIRE. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES. THE DEVICE DID NOT CATCH FIRE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846264 PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 24D5261 07613327051872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown