BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM

    MDR report key: 8716919 · Received June 20, 2019

    Report

    Report Number
    0002936485-2019-00252
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 21, 2019
    Report Date
    August 12, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    UDI-DI
    07613252633181
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: SEAM WHERE POLYMER TIP MEETS METAL SHAFT OF FLOWPORT CANNULA BROKE. PROBABLE ROOT CAUSE: DESIGN - INADEQUATE MATERIAL SELECTION TO SUPPORT MOVEMENT/MANIPULATION BY USER - INADEQUATE MOLDING/ASSEMBLY DESIGN, POOR STRENGTH OF DESIGN MANUFACTURING - CANNULA NOT ASSEMBLED, MOLDED OR MACHINED TO SPECIFICATION APPLICATION - EXCESSIVE FORCE THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA CRACKED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA CRACKED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508874 FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM ACCESSORIES, ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE UNK 07613252633181

    Patients

    Seq Age Sex Outcome Treatment
    1