BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 4141327 · Received October 3, 2014

    Report

    Report Number
    0002936485-2014-00785
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 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 UNIT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE FOLLOWING REPAIR AND SERVICE DIAGNOSTIC CODES WERE IDENTIFIED: LAP-R-K48: SCRATCHES ON INSULATION. LAP-P4Q: REPLACED HANDLE. THE FOLLOWING WAS OBSERVED: A BROKEN/FRACTURED HANDLE. THE HANDLE WAS REPLACED. THIS DOES CONFIRM THE ALLEGED FAILURE MODE OF FAILED INSULATION. PROBABLE ROOT CAUSE: POOR AUTOCLAVE RELIABILITY. INCORRECT STERILIZATION/REPROCESSING PROCEDURE. HANDLING PROCEDURES. CONTACT FORCES. PRODUCT USED BEYOND DEFINED USEFUL LIFE. IN SUM, THE UNIT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    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
    619873 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 09102014

    Patients

    Seq Age Sex Outcome Treatment
    1