BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM

    MDR report key: 6015922 · Received October 10, 2016

    Report

    Report Number
    0002936485-2016-00953
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    March 21, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: TIP BROKE OFF PROBABLE ROOT CAUSE: DESIGN : TIP NOT SHARP ENOUGH. PROCESS: TIP NOT MANUFACTURED TO SPECIFICATION. APPLICATION: IMPROPER INSERTION, NOT ENOUGH FORCE DURING INSERTION. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE 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 THE CANNULA BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667095 FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM ACCESSORIES,ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE 16042101

    Patients

    Seq Age Sex Outcome Treatment
    1