BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR HANDLE 33CM

    MDR report key: 3831292 · Received May 24, 2014

    Report

    Report Number
    0002936485-2014-00350
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE HANDLE WAS VISUALLY INSPECTED FOR DAMAGES, AND THE INSULATION HAS PEELED OFF OF THE HANDLE. THE INSULATION INTEGRITY WAS TESTED AND FAILED NEAR THE DISTAL END. THE PROBABLE ROOT CAUSES COULD BE HANDLING DURING PROCESSING/CLEANING, OR NORMAL WEAR. 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 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
    309648 5MM MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0943591D

    Patients

    Seq Age Sex Outcome Treatment
    1