BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA ELITE SYSTEM RESECTOSCOPE METAL SHEATH

    MDR report key: 2926150 · Received January 16, 2013

    Report

    Report Number
    1519132-2013-00001
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED INSTRUMENT CONFIRMS THAT A CERAMIC TIP HAS BEEN BROKEN OFF FROM THE TUBE OF THE DEVICE. THE WHITE CERAMIC TIP ON THE INSTRUMENT IS FROM A THIRD PARTY, THE TIP OF THE INSTRUMENT SHOULD BE A BLACK FIBERGLASS TIP. ALSO NOTED IS HOW THE TIP DOES NOT MEET WITH THE TUBE, CAUSING THE LEDGE. THE TUBE ALSO HAS MULTIPLE DENTS AND RIPPLES. THE EVIDENCE NOTED ABOVE CLEARLY INDICATES THAT THE INSTRUMENT HAS BEEN REPAIRED BY A THIRD PARTY AND IS THE LIKELY CAUSE OF THE FAILURE DURING THE PROCEDURE. THE DETERMINATION OF THE USE OF A THIRD PARTY REPAIR FACILITY ON THIS DEVICE IS OF GREAT CONCERN BECAUSE GYRUS ACMI HAS NO CONTROL OF THE QUALITY OF THE REPAIR IN THIS TYPE OF SITUATION.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE TIP BROKE AND FELL INTO THE PT. THE SURGEON RETRIEVED THE TIP FROM THE PT WITH NO HARM OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24214 USA ELITE SYSTEM RESECTOSCOPE METAL SHEATH RESECTOSCOPE METAL SHEATH HIH GYRUS ACMI, INC. EMRS-24

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK