BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    MDR report key: 3573343 · Received November 1, 2013

    Report

    Report Number
    1526350-2013-00642
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 3, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO NONCONFORMANCES DURING MANUFACTURE THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP FROM THE ZIMMER PULSAVAC PLUS POPPED OFF DURING SURGERY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT DURING AN ABDOMINAL SURGICAL PROCEDURE, THE FAN SPRAY TIP FELL OFF AFTER COMING IN CONTACT WITH THE TISSUE. THE TIP WAS RETRIEVED AFTER MINOR MANUAL EXPLORATION OF THE CAVITY. THERE WAS NO IMPACT TO THE PROCEDURE, PATIENT OR USER AS A RESULT OF THE TIP FALLING OFF. THE PROCEDURE WAS COMPLETED USING THE SAME PULSAVAC, WHICH WAS DISCARDED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564956 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN GQH ZIMMER SURGICAL NA 62447466

    Patients

    Seq Age Sex Outcome Treatment
    1