BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 4872667 · Received June 26, 2015

    Report

    Report Number
    0002936485-2015-00535
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION. THE INSTRUMENT FAILED THE INSUL SCAN TEST. THE PROBABLE ROOT CAUSES ARE NORMAL WEAR, USER MISUSE AND IMPROPER STERILIZATION METHODS THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS 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 THE INSULATION HAD BEEN COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAD BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413824 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE ¿1040689D¿

    Patients

    Seq Age Sex Outcome Treatment
    1