BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM PEEK MULTIFUNCTION HANDLE

    MDR report key: 3932462 · Received July 14, 2014

    Report

    Report Number
    0002936485-2014-00488
    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

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE INSULATION OF THE MONOPOLAR HANDLE IS CRACKED NEAR THE DISTAL END OF THE SHAFT. THE HANDLE FAILED AN INSULATION INTEGRITY TEST. PROBABLE ROOT CAUSES COULD BE USER ERROR OR HANDLING DURING CLEANING/STERILIZATION. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    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
    410954 5MM PEEK MULTIFUNCTION HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 1245860D

    Patients

    Seq Age Sex Outcome Treatment
    1