BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM, 33CM PEEK MULTI-FUNCTION HANDLE

    MDR report key: 3081640 · Received April 29, 2013

    Report

    Report Number
    0002936485-2013-00177
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. A CRACK ON THE INSULATION WAS SEEN NEAR THE DISTAL TIP. THE INSULATION FAILED THE INSULATION SCAN TEST. THE PROBABLE ROOT CAUSES COULD BE USER MISUSE, IMPROPER STERILIZATION METHODS, AND/OR NORMAL WEAR. IN SUM, 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 OF THE DEVICE WAS COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION OF THE DEVICE WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183503 10MM, 33CM PEEK MULTI-FUNCTION HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0944829D

    Patients

    Seq Age Sex Outcome Treatment
    1