BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIPS DUAL 2 MINUTE TIP

    MDR report key: 3934040 · Received July 15, 2014

    Report

    Report Number
    0001811755-2014-02511
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIPS DUAL 2 MINUTE TIP FELL OFF AND INTO THE SURGICAL SITE DURING A PROCEDURE. THE TIP WAS REMOVED BY HAND AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414191 SIPS DUAL 2 MINUTE TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 14116012

    Patients

    Seq Age Sex Outcome Treatment
    1