BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1188HD CAMERA HEAD

    MDR report key: 3180647 · Received June 20, 2013

    Report

    Report Number
    0002936485-2013-00265
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K983566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE MOST LIKELY ROOT CAUSE FOR POOR IMAGE CAN BE DUE TO A SYSTEM SET UP ISSUE WHERE THE SIGNAL WAS SET ON AN ANALOG OR S VIDEO INSTEAD OF DVI SIGNAL. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, POOR IMAGE QUALITY WAS OBSERVED. THE PROCEDURE WAS STOPPED DUE TO POOR VISUALIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, POOR IMAGE QUALITY WAS OBSERVED. THE PROCEDURE WAS STOPPED DUE TO POOR VISUALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280530 1188HD CAMERA HEAD LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1