BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATH, 2.9MM OPERATIVE INNER

    MDR report key: 5674790 · Received May 23, 2016

    Report

    Report Number
    0002936485-2016-00492
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FAJ
    PMA / PMN Number
    K040390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: RUST AND METAL DEBRIS. PROBABLE ROOT CAUSE: MATERIAL/DESIGN ERROR. MANUFACTURING/ASSEMBLY ERROR. INADEQUATE PACKAGE SEAL STRENGTH (PACKAGING DESIGN). IMPROPER CLEANING/STERILIZATION FOR REUSABLE DEVICES". THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BIOPSY PUNCH, BIOBURDEN, RUST AND SHINY MATERIAL CAME OUT ODF THE CANNULA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BIOPSY PUNCH, BIOBURDEN, RUST AND SHINY MATERIAL CAME OUT OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327719 SHEATH, 2.9MM OPERATIVE INNER CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FAJ STRYKER ENDOSCOPY-SAN JOSE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1