BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 32CM STRYKEPROBE L-TIP

    MDR report key: 1970314 · Received January 14, 2011

    Report

    Report Number
    2936485-2011-00022
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT BROKE AFTER BEING AUTOCLAVED. IT WAS FURTHER REPORTED THAT THE SOLDER ON THE UNIT CAME OFF IN ADDITION TO THE L-TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM X 32CM STRYKEPROBE L-TIP SUCTION/IRRIGATION GCX STRYKER ENDOSCOPY SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK