BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 45CM PEEK MULTI-FUNCTION HANDLE

    MDR report key: 3974244 · Received August 1, 2014

    Report

    Report Number
    0002936485-2014-00566
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 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 INSPECTION OF THE 5MM, 45CM PEEK MULTI-FUNCTION HANDLE CONFIRMS INSULATION DAMAGE, SCRATCHES DINGS AND DENTS WERE SEEN THROUGHOUT THE SHAFT. THE 5MM, 45CM PEEK MULTI-FUNCTION HANDLE FAILED THE INSULSCAN TEST. PROBABLE ROOT CAUSE/S COULD BE USE ERROR, MISHANDLING AND OR NORMAL WEAR AND TEAR. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    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
    449854 5MM, 45CM PEEK MULTI-FUNCTION HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 07092014

    Patients

    Seq Age Sex Outcome Treatment
    1