BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM RATCHETED HANDLE 33CM

    MDR report key: 3842515 · Received June 2, 2014

    Report

    Report Number
    0002936485-2014-00371
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE VISUAL INSPECTION OF THE DEVICE CONFIRMS INSULATION DAMAGE THROUGHOUT THE SHAFT. AN INSULATION INTEGRITY TEST WAS CONDUCTED AND THE DEVICE FAILED. THE PROBABLE ROOT CAUSE/S FOR THE INSULATION DAMAGE COULD BE INCORRECT STERILIZATION METHODS AND OR NORMAL WEAR AND TEAR. 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 UNIT HAD COMPROMISED INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD COMPROMISED INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321728 5MM RATCHETED HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 1242265

    Patients

    Seq Age Sex Outcome Treatment
    1