BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM SHOW

    MDR report key: 4202671 · Received May 7, 2014

    Report

    Report Number
    1526350-2014-00352
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    February 17, 2014
    Report Date
    April 19, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS WAS PERFORMED AND IDENTIFIED NO RELATED NONCONFORMANCE DURING MFR. ALTHOUGH THE SPECIFIC DEVICE INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED TO THE MFR, THE CAUSE OF THE COMPLAINT WAS CONTRIBUTED TO THE PRESS FIT TIP LOCKING MECHANISM ON THE PULSAVAC PLUS. A DESIGN CHANGE HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM SHOWER SPRAY KIT WAS MISSING THE BLUE "COLLAR" OR "CLIP" THAT HOLDS THE HIGH CAPACITY SHOWER SPRAY TIP ON. THIS WAS NOTICED DURING SURGERY, WHERE THE TIP OF THE DEVICE KEPT FALLING OFF AND HAD TO BE HELD ON BY THE SURGEON. AT THE TIME THE TIP DETACHED FROM THE HANDPIECE, IT FELL OFF INTO THE SURGICAL FIELD INSIDE THE WOUND. THE TIP WAS MANUALLY RETRIEVED BY MANUAL EXPLORATION OF THE WOUND. IT WAS FURTHER REPORTED THAT ROOM STAFF WAS PROTECTED BY PERSONAL PROTECTIVE EQUIPMENT INCLUDING FULL SURGICAL GOWNS WITH A HOOD, WHICH ALLOWED THEM NOT TO COME INTO CONTACT WITH THE IRRIGATION FLUID WHEN IT SPRAYED. IT WAS NOTED THAT THE CIRCULATING NURSE, CERTIFIED REGISTERED NURSE ANESTHETIST WAS NOT WEARING FULL PERSONAL PROTECTIVE EQUIPMENT BUT WAS NOT IN REACH OF THE SPRAY. THERE WAS NO HARM TO THE PT OR USER IDENTIFIED AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277029 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM SHOW PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FQH ZIMMER SURGICAL NA 62441040

    Patients

    Seq Age Sex Outcome Treatment
    1