BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG L9000 LIGHT SOURCE

    MDR report key: 8933026 · Received August 26, 2019

    Report

    Report Number
    0002936485-2019-00359
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 31, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    UDI-DI
    07613327051339
    PMA / PMN Number
    K082813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: NON-STRYKER SCOPE BURNED THROUGH DRAPE CONNECTED TO L9000. PROBABLE ROOT CAUSE: REED SWITCH ASSEMBLY MALFUNCTION. USE ERROR. SERIAL NUMBER IS UNKNOWN; THEREFORE, MANUFACTURE DATE CAN NOT BE CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THERMAL EVENT OCCURRED. A SCOPE BURNED THROUGH DRAPE CONNECTED TO LIGHT SOURCE. PROCEDURE COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A THERMAL EVENT OCCURRED. A SCOPE BURNED THROUGH DRAPE CONNECTED TO LIGHT SOURCE. PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727220 PKG L9000 LIGHT SOURCE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE 07613327051339

    Patients

    Seq Age Sex Outcome Treatment
    1