BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER STANDARD VIDEO CART W/ISOLATION TRANSFORMER

    MDR report key: 1900928 · Received November 10, 2010

    Report

    Report Number
    2936485-2010-00825
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 26, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MALE PIN ON THE POWER CORD ATTACHED TO THE UNIT MELTED INTO ANOTHER CORD. IT WAS UNK HOW THE PIN WAS BEING USED AT THE TIME OF THE INCIDENT. IT WAS FURTHER REPORTED THAT THE UNIT HAD TO BE REMOVED FROM SERVICE. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER STANDARD VIDEO CART W/ISOLATION TRANSFORMER CART KOG STRYKER ENDOSCOPY SAN JOSE 090122AM007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK