BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF 2 PROBES, 90-S MAX

    MDR report key: 9148027 · Received October 2, 2019

    Report

    Report Number
    0002936485-2019-00448
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 4, 2019
    Report Date
    December 17, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    UDI-DI
    07613327057027
    PMA / PMN Number
    K071859
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: TIP BRPROBABLE OKE. ROOT CAUSE: NON-CONFORMING COMPONENT, POOR ASSEMBLY PROCESS, MISUSE. USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE AND WAS NOT RETRIEVED FROM THE JOINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE AND WAS NOT RETRIEVED FROM THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937809 RF 2 PROBES, 90-S MAX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 18201AE2 07613327057027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other