BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP

    MDR report key: 2090245 · Received April 19, 2011

    Report

    Report Number
    2648666-2011-00108
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. NO LOT NUMBER HAS BEEN PROVIDED FOR A DEVICE HISTORY RECORD REVIEW. IF ADD'L INFO IS REC'D, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE TIP FELL OFF DURING AN OPEN VASCULAR CASE. NOTHING FELL INTO THE SITE AND NO SIGNIFICANT DELAY WAS NOTED. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP FQH STRYKER INSTRUMENTS PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK