BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT POWER CORD FOR TEKNA CARTS

    MDR report key: 1767721 · Received July 15, 2010

    Report

    Report Number
    2936485-2010-00554
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 14 POWER CORDS WERE RETURNED FOR INVESTIGATION. FIVE POWER CORDS WERE FROM LOT 100624. THE OTHER 9 WERE FROM AN UNSPECIFIED LOT. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT HAD BENT BLADES AND/OR BENT PRONGS THAT ARE PARTIALLY CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT POWER CORD FOR TEKNA CARTS CORD KNS STRYKER ENDOSCOPY SAN JOSE 100624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK