BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL SETTING CLAMP

    MDR report key: 8232518 · Received January 9, 2019

    Report

    Report Number
    8010652-2019-00002
    Event Type
    Injury
    Date Received
    January 9, 2019
    Report Date
    March 6, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). A GETINGE- MAQUET SERVICE TECH WAS ON SITE AND EXAMINED THE PRODUCT. NO DEFECT WAS FOUND DURING THE INSPECTION. FURTHER DETAILS ON THE INCIDENT WERE REQUESTED FROM THE CUSTOMER BUT WERE NOT AVAILABLE. AS SOON AS THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW-UP REPORT WILL BE PROVIDED.

    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. (B)(4). CONTACT PERSON: (B)(6). THE CUSTOMER DESCRIBED THAT DURING A PROCEDURE A SCREW ON THE RADIAL SETTING CLAMP LOOSENED AND A PATIENT INJURY OCCURRED. THE CLAMP IS MOUNTED ON THE TABLE BY TIGHTENING A DROP TOGGLE SCREW. AN ACCESSORY IS MOUNTED TO THE CLAMP BY TIGHTENING A TOMMY SCREW. A GETINGE, MAQUET SERVICE TECHNICIAN VISITED THE CUSTOMER AND INVESTIGATED THE AFFECTED PRODUCT. HE COULD NOT DETECT ANY DAMAGE OR MALFUNCTION ON THE AFFECTED PRODUCT. FURTHER MORE DETAILED INFORMATION REGARDING THE PATIENT INJURY AND MALFUNCTION OF THE PRODUCT WAS REQUESTED SEVERAL TIMES FROM THE CUSTOMER, BUT NOT PROVIDED. DUE TO THE DESCRIBED ISSUE AND SINCE NO DEFECT COULD BE FOUND, WE ASSUME THAT THIS ISSUE OCCURRED DUE TO A USE ERROR. WE ASSUME THAT THE SCREWS WERE NOT TIGHTENED PROPERLY OR LOOSENED UNINTENTIONALLY OR THE PRODUCT WAS OVERLOADED OR AN UNFORTUNATE COMBINATION OF ALL OF THE BEFORE MENTIONED OCCURRED. IN THE INSTRUCTIONS FOR USE (IFU) THE PROCEDURES TO MOUNT THE CLAMP TO THE TABLE AND TO MOUNT THE ACCESSARY TO THE CLAMP ARE DESCRIBED. THE CUSTOMER IS TOLD IN THE IFU TO TIGHTEN THE DROP TOGGLE SCREW AND THE TOMMY SCREW FIRMLY AND CHECK PROPER SEATING AFTERWARDS. FURTHER THE CUSTOMER IS WARNED IN THE IFU REGARDING THE RISKS RELATED TO LOOSE SECURING ELEMENTS. QUOTES IFU: "WARNING! RISK OF INJURY! PRODUCTS / ACCESSORIES NOT ATTACHED PROPERLY MAY LOOSEN AND CAUSE INJURIES. ENSURE THAT PRODUCTS / ACCESSORIES ARE MOUNTED CORRECTLY AND THAT THE SECURING ELEMENTS (HANDLE SCREWS, CATCHES, LEVERS, ETC.) ARE CLOSED AND FIRMLY TIGHTENED, ALSO ENSURE THAT MOVING PARTS ARE CORRECTLY SECURED." "WARNING! RISK OF INJURY! IF LOCKING ELEMENTS (ECCENTRIC LEVERS, HANDLE SCREWS, LOCKS ETC.) ARE OPEN, THE PRODUCT/ACCESSORY CAN BE MOVED. BEFORE OPENING THE LOCKING ELEMENTS, HOLD THE INDIVIDUAL ITEMS FIRMLY. AFTER EVERY ADJUSTMENT PROCEDURE, ENSURE THAT ALL LOCKING ELEMENTS ARE CLOSED." THE MAXIMUM LOAD THAT SHOULD BE PLACED ON THE PRODUCT IS STATED IN THE IFU AND THE USER IS WARNED REGARDING THE RISKS RELATED TO OVERLOAD. QUOTES IFU: "WARNING! RISK OF INJURY DUE TO MATERIAL FAILURE! THE MAXIMUM LOAD THAT MAY BE PLACED ON THE PRODUCT IS 34.5 KG." "RISK OF INJURY DUE TO OVERLOADING! THE PERMITTED LOAD OF THE PRODUCT DEPENDS ON THE COMBINATION OF ACCESSORIES USED. THE PRODUCT WITH THE LOWEST PERMISSIBLE LOAD DETERMINES THE MAXIMUM LOAD IN THE EVENT THAT IT IS COMBINED WITH OTHER ACCESSORIES. REFER TO THE OPERATING INSTRUCTIONS OF EACH ACCESSORY FOR THE PERMISSIBLE LOAD." MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    WE WERE INFORMED THAT DURING A PROCEDURE A SCREW ON THE RADIAL SETTING CLAMP LOOSENED AND A PATIENT INJURY OCCURRED. 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
    24382 RADIAL SETTING CLAMP ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ HOLGER ULLRICH 100323CO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other