BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8405, XXL ALEXIS O WND PRO/RET 5/BX

    MDR report key: 7038231 · Received November 16, 2017

    Report

    Report Number
    2027111-2017-02114
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 18, 2017
    Report Date
    December 6, 2017
    Manufacturer
    APPLIED MEDICAL
    Product Code
    KGW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS A RESULT, THE COMPLAINANT'S EXPERIENCE COULD NOT BE CONFIRMED. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCT. BASED ON ADDITIONAL INFORMATION THAT WAS RECEIVED, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY AN OVERSIZED INCISION. HOWEVER, IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED - LAPAROTOMIE = LAPAROTOMY. EVENT DESCRIPTION - BIJ HET PLAATSEN VAN DE ALEXIS XXL WERD GECONSTATEERD DAT DE ALEXIS XXL NIET GEHEEL DE WONDRANDEN BEDEKT. DE FUNCTIE VAN WONDBESCHERMING GAAT DAN VERLOREN. DE BUIKWAND MET VET DRKT ZICH BUITEN DE ALEXIS XXL. TRANSLATION RA-QA: WHEN PLACING THE ALEXIS XXL IT WAS DISCOVERED THAT THE ALEXIS XXL DOES NOT COMPLETELY COVER THE WOUND EDGES. THE FUNCTIONALITY OF THE WOUND PROTECTION THEN BECOMES LOST/INEFFECTIVE. THE ABDOMINAL WALL WITH FAT THEN PUSHES ITSELF OUTSIDE THE ALEXIS XXL. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON NOVEMBER 3, 2017 FROM SR CLINICAL DEVELOPMENT MGR: "INFORMATION FROM APPLIED MEDICAL TEAM MEMBER OCTOBER 25, 2017: LAST WEEK I ATTENDED AN OPEN GYN CASE WHERE THE ALEXIS O XXL WAS USED. THEY PERFORMED AN HYSTERECTOMY AND AS A SAMPLING REMOVED TEN GLANDS FROM ALL DIFFERENT REGIONS. THE MIDLINE INCISION RAN FROM THE PUBIC SYMPHYSIS AROUND THE UMBILICUS AND 2- CM UPWARDS, ACCORDING TO THE SURGEON AN APPROXIMATELY 25 CM INCISION. THE PATIENT WAS (B)(6) FEMALE WITH A (B)(6). HER LARGER POSTURE WAS QUITE CENTERED AROUND HER BELLY AREA. COMPLICATION: THE ALEXIS XXL WAS UNABLE TO COVER THE WOUND MARGINS COMPLETELY. THE WOUND MARGIN POPPED OUT ON TWO SIDES. WE ADVISED TO LOOSEN THE RING BY FLIPPING IT BACK TWO TIMES, THIS IMPROVED THE SITUATION BUT THE WOUND MARGINS WERE STILL EXPOSED AT THE TWO SIDES (JUST A BIT LESS). HOWEVER, FLIPPING THE ALEXIS O BACK, ALSO RESULTED IN LOSING A BIT OF THE RETRACTION. IN THE END, THE SURGEON WASN'T COMPLETELY SATISFIED WITH THE EXPOSURE AND SWITCHED TO MUNSTER RETRACTOR. SHE PREFERRED THE [COMPETITOR] RETRACTOR OVER THE ALEXIS O, HOWEVER, SHE APPRECIATED THAT ALEXIS O WAS SO QUICK TO SET UP. INFORMATION FROM APPLIED MEDICAL TEAM MEMBER OCTOBER 26, 2017: THE EXPOSED WOUND MARGINS (ON TWO SIDES) WITH THE ALEXIS XXL LOOKED SIMILAR TO THE DRAWING BELOW" PATIENT STATUS - NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT TYPE OF INTERVENTION - N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817670 C8405, XXL ALEXIS O WND PRO/RET 5/BX KGW KGW APPLIED MEDICAL C8405 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1