BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE

    MDR report key: 3143570 · Received June 3, 2013

    Report

    Report Number
    0002936485-2013-00244
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    June 1, 2011
    Report Date
    May 22, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FSS
    PMA / PMN Number
    K961971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. BASED ON THE EVENT DESCRIPTION, THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO INCORRECT LIGHT OUTPUT EMITTED BY THE COMPETITOR LIGHT SOURCE. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT HAS NOT BEEN RETURNED. ADDITIONALLY, STRYKER DOES NOT INDICATE COMPATIBILITY OF THE LIGHT CABLE WITH A COMPETITOR LIGHT SOURCE. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE 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 CABLE WAS USED WITH ANOTHER MANUFACTURER LIGHT SOURCE RESULTING IN PATIENT BURNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT CABLE WAS USED WITH ANOTHER MANUFACTURE LIGHT SOURCE RESULTING IN PATIENT BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245098 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE LIGHT, SURGICAL, FLOOR STANDING FSS STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1