BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 3932006 · Received July 14, 2014

    Report

    Report Number
    0002936485-2014-00485
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORACLE SERVICE RECORD CONFIRMS THE DEVICE HAS BEEN REPAIRED BEFORE AN INVESTIGATOR WAS ABLE TO PERFORM A FULL EVALUATION; THEREFORE THIS COMPLAINT INVESTIGATION WILL NOW BE CLOSED BASED ON THE REPAIR FINDINGS, AND PROBABLE ROOT CAUSE(S). THE PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: USER MISUSE, IMPROPER STERILIZATION METHODS, OR NORMAL WEAR THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED THROUGH THE SERVICE REPAIR. 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 HAS BEEN COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409275 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 06232014

    Patients

    Seq Age Sex Outcome Treatment
    1