BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1:1 CONTRA ANGLE HEAD W/INTERNAL IRRIGATION

    MDR report key: 1942304 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02099
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 24, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K961970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT OVERHEATED DURING A SURGICAL PROCEDURE. THE CASE WAS COMPLETED AS INTENDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1:1 CONTRA ANGLE HEAD W/INTERNAL IRRIGATION SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM HWE STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK