BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMALGATOME

    MDR report key: 7361204 · Received March 22, 2018

    Report

    Report Number
    3011981870-2018-00320
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    March 5, 2018
    Report Date
    March 20, 2018
    Manufacturer
    EXSURCO MEDICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT WAS REPORTED, CUSTOMER ALLEGED THAT THE HOSE BURST ON THE AMALGATOME SD IN THE BURN OR. THIS OCCURRED WHEN THE USER (DR. (B)(6)) WAS CHANGING THE FOUR-INCH HEAD ASSEMBLY TO THE TWO INCH HEAD ASSEMBLY. THE SURGICAL TECHNICIAN IN THE ROOM ALLEGEDLY WAS INJURED. SURGICAL TECHNICIAN CONFIRMED THAT A SUPERFICIAL ABRASION AND A SPRAINED KNEE WAS SUSTAINED. THE KNEE INJURY WAS ALLEGEDLY CAUSED BY THE TECHNICIAN BEING STARTLED WITH THE LOUD NOISE AND STEPPING BACK ON A WET FLOOR AND SPRAINING HIS KNEE REQUIRING A VISIT TO THE ER AND FURTHER PHYSICAL THERAPY. THERE WAS NO INJURY TO THE PATIENT REPORTED. THERE WAS NO DELAY IN PROCEDURE REPORTED. THE AMALGATOME SD (SDSYSTEM024-EVAL) WAS RETURNED ON 03/12/2018 (INCLUDING X101004-HOSE/SN#:(B)(4)). INITIAL EVALUATION OF THE UNIT CONFIRMED THAT THE DEVICE WAS TO SPECIFICATION. INVESTIGATION IS ONGOING AS ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. INITIALLY REPORTED THAT THE DEVICE WAS USED AT 100 PSI AS RECOMMENDED BY OEM. SUBSEQUENTLY IT WAS REPORTED THAT THE DEVICE MAY HAVE BEEN USED AT A HIGHER PSI (150-170).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205822 AMALGATOME AMALGATOME SD (ASD) GFD EXSURCO MEDICAL, INC. SDSYSTEM024-EVAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other