BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 2900138 · Received December 27, 2012

    Report

    Report Number
    2648666-2012-00367
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    PMA / PMN Number
    K991960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE IMPLANT SURGEON WAS PERFORMING A PROCEDURE, HE NOTICED THAT A PIECE OF THE TIP HAD BEEN BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERFAS ENERGY SUPER 90-S GEI STRYKER ENDOSCOPY PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK