BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 45CM MONOPOLAR HANDLE

    MDR report key: 3790965 · Received May 5, 2014

    Report

    Report Number
    0002936485-2014-00305
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE SHAFT OF THE DEVICE IS SLIGHTLY BENT. ALSO RUST WAS SEEN ON THE PROXIMAL END WHERE THE SHAFT MEETS THE HANDLE. ALSO THERE IS A BURN MARK ON THE DISTAL END OF THE INSULATION, HOWEVER THE DEVICE PASSED AN INSULATION TEST. THE PROBABLE ROOT CAUSE/S ARE USER MISUSE, INCORRECT CLEANING/STERILIZATION METHODS AND HANDLING DURING INSPECTION, CLEANING, OR STERILIZATION. 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
    267580 5MM, 45CM MONOPOLAR HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0744685D

    Patients

    Seq Age Sex Outcome Treatment
    1