BEUDAMED
    FDA Adverse Event Injury Summary report: N

    988 CAMERA CONTROL UNIT

    MDR report key: 2097634 · Received May 16, 2011

    Report

    Report Number
    2936485-2011-00333
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONSOLE SHUT DOWN DURING THE SURGERY. IT WAS FURTHER REPORTED THAT IN THE BEGINNING, THE CONSOLE WAS FUNCTIONING AND MONITORED. THE DOCTOR THEN NOTICED THE MONITOR HAD NO IMAGE (BLACK OUT) WHEN HE TOOK THE SCOPE OUT FROM THE SHEATH AND INSERTED IT AGAIN, AS HE NEEDED TO WIPE IT AS IT WAS MOISTURED AFTER INSERTION OF THE TROCAL WATCHING THE MONITOR. ALL THE DEVICES WERE CHECKED AND FOUND THAT THE CONSOLE SHUT DOWN (ALL THE LED/LAMPS/INDICATORS ON THE FRONT PANEL WERE BLACKED OUT). THE CALLED THE SALES REP AND TECHNICAL CENTER FOR A BACKUP DEVICE BUT IT WOULD TAKE MORE THAN 1 HOUR, SO THE DOCTOR EXPLAINED IT TO THE PATIENT'S FAMILY AND PERFORMED AN OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 988 CAMERA CONTROL UNIT CCU FXM STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other