BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 1945303 · Received December 27, 2010

    Report

    Report Number
    2648666-2010-00501
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REGISTERED NURSE AT THE FACILITY WAS REMOVING THE STRYKEFLOW2 WITHOUT TIP FROM THE CASE AND THEY NOTICED A FEW HAIR STRANDS INSIDE THE CASE. IT WAS FURTHER REPORTED THAT ONE OF THE STRYKEFLOW2 WITHOUT TIP HAD ACTUAL PIECE OF HAIR INSIDE THE SEAL OF THE CONTAINER. IT WAS FURTHER REPORTED THAT DISCOVERY OF THE HAIR STANDS DID NOT OCCUR DURING ANY CASE, THUS, THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) STRYKEFLOW GCX STRYKER ENDOSCOPY PUERTO RICO 10313FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK