BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMALGATOME

    MDR report key: 13005860 · Received December 14, 2021

    Report

    Report Number
    3011981870-2021-01829
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 14, 2021
    Manufacturer
    EXSURCO MEDICAL, INC.
    Product Code
    GFD
    UDI-DI
    00810006780000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: HOSE WAS PURCHASED IN (B)(6) OF 2021. MEDICAL STUDENT WENT TO MEDICAL SERVICES FOR OBSERVATION. EXSURCO REPRESENTATIVE WILL BE VISITING THE FACILITY 11/20-11/23. HE IS GOING TO FOLLOLW UP ON THE MEDICAL STUDENT AND ALSO SEE OF THE HOSE IS BEING RETURNED. THE HOSE WAS RETURNED AND AN EVALUATION WAS CONDUCTED. A VISUAL INSPECTION WAS CONDUCTED BY EXSURCO QUALITY, DESIGN ENGINEERING AND MANUFACTURING ENGINEERING. UPON ARRIVAL THE HOSE DID HAVE A FAILURE ON THE END WHERE THE DRIVE UNIT ATTACHES. THE OUTER HOSE WAS CUT OPEN AND DURING THE INSPECTION IT WAS NOTED THAT THE INTERNAL HOSE HAD FAILED AND THEREFORE CAUSED A FAILURE OF THE OUTER HOSE. THE FERRULE APPEARED TO BE IN GOOD SHAPE AND EVENLY CRIMPED WITH THE INTERNAL HOSE FAILURE OCCURRING JUST AFTER THE FERRULE. THE REST OF THE OUTER HOSE AND END FITTINGS APPEAR TO BE IN GOOD WORKING CONDITION EXCEPT FOR A FEW KNICKS AND CUTS. HOSE IS OUT OF WARRANTY, SERIAL # (B)(4). THE DRIVE UNIT/HAND PC (SN # (B)(4)) AND 4INCH BLADE HEAD ASSEMBLY (SD4201805220060) WERE RETURNED FOR AN EVALUATION AS WELL. IT WAS DETERMINED THAT THE HANDPC WAS NOT LUBRICATED AS DIRECTED IN THE USER GUIDE. DUE TO LACK OF MINERAL OIL, INITIALLY THE DEVICE DID NOT RUN AT 90 PSI. UPON ADDING SOME MINERAL OIL, THE HAND PC FUNCTIONED AS INTEDED (SEE SRO (B)(4)).

    Description of Event or Problem · 0

    EXSURCO REPRESENTATIVE RECEIVED THE CALL ABOUT THEIR SD HOSE ALLEGEDLY BURSTING IN THE OPERATING ROOM FROM (B)(6), HE GAVE THE VP OF SALES CONTACT INFORMATION TO FOLLOW UP. VP OF SALES SPOKE TO (B)(6), SHE EXPLAINED THE FOLLOWING EVENTS:THE SCRUB TECH ASSEMBLED THE DEVICE AND TESTED THE ASD AND THEN PASSED THE DEVICE TO THE SURGEON WHO TESTED IT AND THE HOSE AT THAT TIME ALLEGEDLY BURST. A MEDICAL STUDENT WITH IN THE STERILE FIELD WAS ALLEGEDLY HIT IN THE NECK (BROKE SKIN) WITH A PIECE OF RUBBER FROM THE HOSE BURST. NO INJURY WAS REPORTED TO THE PATIENT. AN ADDITIONAL EMAIL FROM EXSURCO REPRESENTATIVE WAS SENT TO (B)(6) TO GATHER ADDITIONAL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED FROM (B)(6): DR. (B)(6) WAS THE SURGEON OPERATING AND WAS TRAINED ON THE DEVICE. THE NITROGEN WAS SET AT 130 PSI DURING USE OF THE DEVICE, VERSUS THE RECOMMENDED 100 PSI. THIS WAS NOT THE FIRST TIME THE SURGICAL TECH ASSEMBLED THE DEVICE. THIS IS A FREQUENT USER. THE SERIAL NUMBER OF THE HOSE IS (B)(4). THERE WAS APPROXIMATELY A 20 MINUTE PROCEDURE DELAY. A BACK UP DERMATOME WAS PULLED AND USED. THE MEDICAL STUDENT IS DOING OKAY, WAS CHECKED AND RESUMED BACK TO WORK. IT IS UNCLEAR IF THE MEDICAL STUDENT RECEIVED MEDICAL ATTENTION. ISSUED RMA EX00000451 FOR THE HOSE AND S000001698 FOR THE RE-USABLE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898115 AMALGATOME AMALGATOME SD GFD EXSURCO MEDICAL, INC. X101004 00810006780000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown