BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ENDOSCOPY_PRODUCT

    MDR report key: 5066182 · Received September 9, 2015

    Report

    Report Number
    0002936485-2015-00803
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    PMA / PMN Number
    K082813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: SAFELIGHT DESIGN, BOOT MATERIAL, LIGHT SOURCE (WHITE LIGHT OUTPUT), USE ERROR. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    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 WHILE USING THE LIGHT CORD, IT BURNED THROUGH THE PATIENT DRAPING. IT WAS REPORTED THAT THE L9000 LIGHT SOURCE WAS ACTIVATED WITH STRYKER CLEAR CASE LIGHT CORD ATTACHED TO A LAPAROSCOPE. IT WAS REPORTED THAT IT WAS LEFT ON TOP OF THE DRAPE COVERING THE PATIENT. IT WAS REPORTED THAT WITHIN 30 SECONDS, A BURN IN THE DRAPE WAS NOTICED, CAMERA HEAD WAS PICKED UP SO SCOPE WAS NO LONGER TOUCHING DRAPE AND LIGHT SOURCE WAS PLACED ON STANDBY. IT WAS REPORTED THAT THE NURSES WERE NOT CERTAIN OF THE LIGHT SOURCE INTENSITY SETTING. PROCEDURE TO BE PERFORMED WAS A LAPAROSCOPIC APPENDECTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE LIGHT CORD, IT BURNED THROUGH THE PATIENT DRAPING. IT WAS REPORTED THAT THE L9000 LIGHT SOURCE WAS ACTIVATED WITH STRYKER CLEAR CASE LIGHT CORD ATTACHED TO A LAPAROSCOPE. IT WAS REPORTED THAT IT WAS LEFT ON TOP OF THE DRAPE COVERING THE PATIENT. IT WAS REPORTED THAT WITHIN 30 SECONDS, A BURN IN THE DRAPE WAS NOTICED, CAMERA HEAD WAS PICKED UP SO SCOPE WAS NO LONGER TOUCHING DRAPE AND LIGHT SOURCE WAS PLACED ON STANDBY. IT WAS REPORTED THAT THE NURSES WERE NOT CERTAIN OF THE LIGHT SOURCE INTENSITY SETTING. PROCEDURE TO BE PERFORMED WAS A LAPAROSCOPIC APPENDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595200 UNKNOWN_ENDOSCOPY_PRODUCT LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1