BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 2102573 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01828
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL. DURING THE INVESTIGATION AN OVERHEATING CONDITION WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS DEBRIS FOUND INSIDE THE DEVICE. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE ATTACHMENT WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE INVESTIGATION THE DEVICE BEGAN OVERHEATING. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD MEDIUM CURVED HBE STRYKER INSTRUMENTS KALAMAZOO 11048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK