BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURLOK FLATWIRE STONE BASKET

    MDR report key: 2099510 · Received April 12, 2011

    Report

    Report Number
    2183680-2011-00012
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED, THE STONE RETRIEVER WAS RETURNED WITH THE BASKET DETACHED FROM THE WIRE SHEATH SUB-ASSEMBLY. THIS APPEARS TO BE A SOLDER JOINT BOND FAILURE BETWEEN THE WIRE COLLAR AND THE BASKET. THE BASKET WAS NOT INCLUDED WITH THE RETURN. AN EMAIL WAS RECEIVED FROM THE HOSPITAL WHICH NOTIFIED GYRUS ACMI THAT THE BASKET WAS RECOVERED FROM THE PATIENT AT A LATER DATE AT A DIFFERENT FACILITY. THE WIRE SHEATH SUB-ASSEMBLY WILL BE REVIEWED WITH THE VENDOR/SUPPLIER TO DETERMINE ROOT CAUSE OF THE JOINT BOND FAILURE. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A KIDNEY STONE PROCEDURE, THE SURGEON GRASPED THE STONE AND ON THE WAY OUT OF THE URETER THE BASKET TIP BROKE OFF IN THE PATIENT, THE SURGEON TRIED TO RETRIEVE THE TIP BUT WAS UNSUCCESSFUL, A SURGERY IS SCHEDULED FOR (B)(6), 2011 TO HAVE THE PIECE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURLOK FLATWIRE STONE BASKET SURLOK FLATWIRE STONE BASKET FFL GYRUS MEDICAL INC. 5710004 8199037

    Patients

    Seq Age Sex Outcome Treatment
    1