BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ENDOSCOPY_PRODUCT

    MDR report key: 2972183 · Received February 21, 2013

    Report

    Report Number
    0002936485-2013-00037
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PART NUMBER REMAINS UNKNOWN SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. ADDITIONALLY, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. PROBABLE ROOT CAUSES FOR THE REPORTED FAILURE COULD HAVE BEEN PROBABLY CAUSED BY: MULTIPLE USES OF FLASH STERILIZATION, RAPID COOLING AFTER STERILIZATION, CONTACT WITH METAL TRAY DURING STERILIZATION, NORMAL WEAR AND TEAR AND/OR IMPROPER STERILIZATION. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. 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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PART NUMBER OF THE UNIT IS UNKNOWN. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE MEDWATCH REPORTS.ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE UNIT HAS BEEN COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE UNIT HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76522 UNKNOWN_ENDOSCOPY_PRODUCT UNK GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1