BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP

    MDR report key: 1935464 · Received December 13, 2010

    Report

    Report Number
    2648666-2010-00484
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONE SHIELD FELL OFF THE TIP PRIOR TO USE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 10270022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK