BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 3982333 · Received August 5, 2014

    Report

    Report Number
    0002936485-2014-00576
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FSS
    PMA / PMN Number
    K961971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    X7000 S/N (B)(4) WAS RETURNED TO STRYKER FOR ANALYSIS, BUT THE FAILURE MODE WAS NOT CONFIRMED.THE CUSTOMER COMPLAINT OF ¿SWITCHED TO STANDBY¿ COULD NOT BE DUPLICATED.VISUAL INSPECTION: THERE WERE NO OUTWARD SIGNS OF COSMETIC OR PHYSICAL DAMAGE TO THE PRODUCT.FUNCTIONAL INSPECTION: ALL MEASUREMENTS AND FUNCTIONALITY TESTING MET SPECIFICATION.PROBABLE ROOT CAUSE: COULD NOT DUPLICATE THE COMPLAINT IN OUR TEST ENVIRONMENT.IN SUM, THE UNIT WAS RETURNED, BUT THE FAILURE MODE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHTSOURCE AUTOMATICALLY SWITCHED TO STANDBY INTERMITTENTLY. THE PROCEDURE WAS LATER SWITCHED TO AN OPEN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHTSOURCE AUTOMATICALLY SWITCHED TO STANDBY INTERMITTENTLY. THE PROCEDURE WAS LATER SWITCHED TO AN OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456808 X7000 XENON LIGHTSOURCE LIGHT, SURGICAL, FLOOR STANDING FSS STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1