BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE

    MDR report key: 2995846 · Received March 8, 2013

    Report

    Report Number
    0002936485-2013-00054
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    December 28, 2012
    Report Date
    February 11, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FSS
    PMA / PMN Number
    K961971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE UNIT WAS FOUND TO HAVE EXCESSIVE BROKEN FIBERS AND A YELLOWISH TINT TO THE OUTER SHEATH; THOSE CONDITIONS INDICATE LONG USAGE. MEASUREMENTS WERE PERFORMED AND THE RESULTS CONCLUDED THAT THE CABLE WAS NOT IN FUNCTIONAL CONDITION AND SHOULD NOT HAVE BEEN USED. FINALLY, THE PRODUCT HAD LOWER TEMPERATURE OUTPUT AS COMPARED TO A NEW OUT-OF-BOX CABLE. IT SHOULD ALSO BE NOTED THAT THE PRODUCT WAS USED WITH A NON-STRYKER PRODUCT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION BUT THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT LEAD WAS PLUGGED INTO A LIGHT BOX AND IMMEDIATELY BECAME HOT. IT WAS FURTHER REPORTED THAT THE LIGHT LEAD BURNT THE OPERATING TABLE MATTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT LEAD WAS PLUGGED INTO A LIGHT BOX AND IMMEDIATELY BECAME HOT. IT WAS FURTHER REPORTED THAT THE LIGHT LEAD BURNT THE OPERATING TABLE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99051 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE LIGHT, SURGICAL, FLOOR STANDING FSS STRYKER ENDOSCOPY-SAN JOSE 175Q

    Patients

    Seq Age Sex Outcome Treatment
    1