BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM, 33CM PEEK MULTI-FUNCTION HANDLE

    MDR report key: 2152872 · Received June 28, 2011

    Report

    Report Number
    2936485-2011-00466
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 THERE WAS A BREAK IN THE INSULATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM, 33CM PEEK MULTI-FUNCTION HANDLE HANDLE HRX STRYKER ENDOSCOPY SAN JOSE 0940172D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK