BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS RF-S WHIRLWIND PROBE

    MDR report key: 2083579 · Received May 10, 2011

    Report

    Report Number
    3003604053-2011-00009
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 12, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE METAL BALL AT THE TIP CAME OFF FROM THE INSTRUMENT AND THE INSULATION RETAINED. ADDITIONAL INFORMATION CONFIRMS THE METAL BALL STILL IN THE PATIENT. THERE IS NO PRODUCT RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS RF-S WHIRLWIND PROBE DYONICS RF-S WHIRLWIND 90 DEG PROBE GEI SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE 72202139 0625400-A

    Patients

    Seq Age Sex Outcome Treatment
    1