BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATH, 2.9MM OPERATIVE INNER

    MDR report key: 4141134 · Received October 3, 2014

    Report

    Report Number
    0002936485-2014-00783
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIH
    PMA / PMN Number
    K040390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION : THE SHEATH, 2.9MM OPERATIVE INNER WAS RECEIVED WITH A DAMAGED DISTAL TIP AND A PIECE OF METAL WAS MISSING ON THE DISTAL TIP.PROBABLE ROOT CAUSE COULD BE THE SHEATH GOT IN CONTACT WITH A SHARP OBJECT DURING USE OR DURING CLEANING. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF DEVICE, A NEW FAILURE MODE OF TIP BREAK HAS BEEN IDENTIFIED, THUS CONSTITUTING A NEW AWARENESS DATE OF THE DATE THE INVESTIGATION RESULTS WERE RECEIVED BY STRYKER. THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION : THE SHEATH, 2.9MM OPERATIVE INNER WAS RECEIVED WITH A DAMAGED DISTAL TIP AND A PIECE OF METAL WAS MISSING ON THE DISTAL TIP. PROBABLE ROOT CAUSE COULD BE THE SHEATH GOT IN CONTACT WITH A SHARP OBJECT DURING USE OR DURING CLEANING. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT IS DAMAGED. UPON RECEIPT OF THE PRODUCT, IT WAS DETERMINED THAT THERE ARE PIECES OF METAL MISSING FROM THE DISTAL TIP OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT IS DAMAGED. UPON RECEIPT OF THE PRODUCT, IT WAS DETERMINED THAT THERE ARE PIECES OF METAL MISSING FROM THE DISTAL TIP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619130 SHEATH, 2.9MM OPERATIVE INNER HYSTEROSCOPE (AND ACCESSORIES) HIH STRYKER ENDOSCOPY-SAN JOSE 1243848

    Patients

    Seq Age Sex Outcome Treatment
    1