BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH HIGH FLOW TIP

    MDR report key: 2962129 · Received January 24, 2013

    Report

    Report Number
    2648666-2013-90018
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVAL. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHITE CAP OF THE SUCTION TIP OF THE INTERPULSE HANDPIECE FELL OUT AND INTO THE SURGICAL SITE DURING A KNEE PROCEDURE. THE SURGEON FOUND AND REMOVED THE CAP AND THE PROCEDURE WAS COMPLETED WITH NO PT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34201 INTERPULSE HANDPIECE WITH HIGH FLOW TIP FQH STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK