BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE FOR SPINAL SURGERY FOR 1180 (EU)

    MDR report key: 7685422 · Received July 13, 2018

    Report

    Report Number
    8010652-2018-00012
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 14, 2018
    Report Date
    January 21, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). GETINGE - MAQUET GMBH SERVICE TECHNICIAN VISITED THE CLINIC AND INVESTIGATED THE PRODUCT IN QUESTION. DEFORMED SNAP FITS WERE FOUND. THE DEFORMED SNAP FITS WERE EXCHANGED. THE CORRECT FUNCTIONALITY, LOCKING AND MOUNT OF THE DEVICE FOR SPINAL SURGERY WAS TESTED AND CONFIRMED. THE DEFORMED SNAP FITS WERE SEND BACK TO THE MANUFACTURER FOR INVESTIGATION. AT THE TIME OF THIS REPORT THE REQUESTED PARTS DIDN'T ARRIVE AND THE INVESTIGATION IS STILL ONGOING. GETINGE - MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, (B)(4). EXEMPTION#: E2018004. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(6). A GETINGE- MAQUET SERVICE TECH VISITED THE CLINIC AND INVESTIGATED THE DEVICE. IT WAS FOUND THAT THE "NOSE" OF THE SNAP FITS WERE DEFORMED. THE SNAP FITS SECURE THE PRODUCT AGAINST UNINTENTIONAL LOOSENING. THE AFFECTED PARTS WERE RETURNED AND INVESTIGATED. THE DESCRIBED DAMAGE COULD BE CONFIRMED. BASED ON THE FAILURE WE ASSUME THAT THE SNAP FITS WERE DAMAGED BY MISTAKE WHEN DEMOUNTING THE PRODUCT FROM THE TABLE TOP. IF THE RELEASE MECHANISM IS NOT ACTUATED DURING DEMOUNTING, HIGH FORCES ACT ON THE SNAP FITS AND CAN DEFORM OR DAMAGE THEM. IN THE INSTRUCTIONS FOR USE (IFU) THE DEMOUNTING PROCEDURE IS DESCRIBED .TWO PEOPLE ARE NEEDED TO DEMOUNT IT. THE USER IS WARNED CONCERNING THE RISKS RELATED TO LOOSENED SECURING ELEMENTS IN THE IFU. THE DEFORMED SNAP FITS WERE EXCHANGED . THE CORRECT FUNCTIONALITY, LOCKING AND MOUNT FOR THE DEVICE FOR SPINAL SURGERY WAS TESTED AND CONFIRMED BY A MAQUET SERVICE TECHNICIAN. GETINGE- MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A PROCEDURE WHEN DEMOUNTING THE DEVICE IT CAME LOOSE AND FELL DOWN ON THE FOOT OF THE NURSE. THE NURSE BROKE ONE TOE. THE ISSUE HAD NO IMPACT ON THE ACTUAL PROCEDURE. MANUFACTURER REFERENCE # (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528651 DEVICE FOR SPINAL SURGERY FOR 1180 (EU) ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ HOLGER ULLRICH 100704DO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other