BEUDAMED
    FDA Adverse Event Other Summary report: N

    BICOAG HEMOSTATIC PROBE

    MDR report key: 2496679 · Received March 14, 2012

    Report

    Report Number
    2183680-2012-00025
    Event Type
    Other
    Date Received
    March 14, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNS
    PMA / PMN Number
    K092571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED, THE PROBE WAS RETURNED WITH THE DISTAL CERAMIC TIP FRACTURED OFF, THE TIP WAS NOT RETURNED WITH THE DEVICE. VISUAL EXAMINATION UNDER MAGNIFICATION SHOWS A CLEAN FRACTURE, THE TIP FRACTURED OFF AT THE SHAFT, THE SHAFT IS STILL FIRMLY BONDED INSIDE THE BODY STOCK TUBING. THE DISTAL END OF THE BODY STOCK IS INTACT AND SHOWS RESIDUAL ADHESIVE AS TO WHERE THE CERAMIC TIP WOULD BE. A REVIEW OF THE DEVICE HISTORY RECORDS DOES NOT INDICATE ANY DISCREPANCIES WITH THE BUILD OF THE LOT. A REVIEW OF THE COMPLAINT DATA BASE FOR THE PAST 15 MONTHS DOES NOT INDICATE ANY OTHER COMPLAINTS FOR THIS FAILURE MODE. AT THIS TIME WE CANNOT DETERMINE WITH CERTAINTY AS TO THE EXACT ROOT CAUSE OF THIS FAILURE. WE WILL CONTINUE TO MONITOR THE COMPLAINT DATA BASED FOR ANY FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    GYRUSACMI WAS NOTIFIED THAT DURING A COLONOSCOPY PROCEDURE WHILE USING A BICOAG HEMOSTATIC PROBE, WHEN INSERTED THROUGH THE SCOPE, THE GOLD CORD END FELL OFF THE END OF THE PROBE INTO THE PT. THE SURGEON ELECTED NOT TO REMOVE THE PIECE SO THAT IT WOULD PASS NATURALLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICOAG HEMOSTATIC PROBE BICOAG HEMOSTATIC PROBE KNS GYRUS MEDICAL, INC. CD-B610LA 273005AD

    Patients

    Seq Age Sex Outcome Treatment
    1