BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY NEEDLE

    MDR report key: 8070518 · Received November 14, 2018

    Report

    Report Number
    3007208013-2018-00026
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 14, 2018
    Manufacturer
    SYMMETRY SURGICAL, INC
    Product Code
    GEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED AS IT IS ON HOLD BY RISK MANAGEMENT AT THE HOSPITAL. WE RECEIVED ADDITIONAL INFORMATION REGARDING THE STATUS OF THE PATIENT. THE BULB OF THE HEPARIN NEEDLE REMAINS IN THE PATIENTS BRAIN AND CANNOT BE REMOVED. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL AND IS ATTENDING PHYSICAL THERAPY. INFORMATION WAS ALSO OBTAINED REGARDING THE LOT NUMBER OF THE DEVICE - 086 WHICH INDICATES THAT THIS DEVICE WAS MANUFACTURED IN JUNE 2008 AND WAS PURCHASED PRIOR TO OUR ACQUISITION OF THE CODMAN PORTFOLIO. WE ARE CONTINUING TO OBTAIN FURTHER INFORMATION, AND A FINAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED A VOLUNTARY EVENT REPORT # MW5080194. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THE ADVERSE EVENT AND CURRENT STATE OF THE PATIENT, THE LOT NUMBER/AGE OF THE PART, AND WHERE THE EVENT OCCURRED/HOSPITAL NAME. ONCE WE HAVE OBTAINED ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT DURING A PROCEDURE FOR A RIGHT CAROTID AND ENDARTERECTOMY. THE ACORN TIP OF THE METAL CANNULA SEPARATED FROM THE REST OF THE CANNULA. THIS OCCURRED WHILE A SOLUTION OF HEPARIN WAS BEING INJECTED INTO THE ARTERY. WHEN THE PATIENT WAS AWAKENED FROM ANESTHESIA, THE PATIENT WAS NOT ABLE TO MOVE EXTREMITIES ON COMMAND. THE PATIENT WAS TAKEN FOR A CAT SCAN AND IT WAS DISCOVERED THAT THE METAL TIP WAS RETAINED IN THE PATIENT. THE PATIENT WAS SENT TO OR AND THE TIP WAS UNABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908937 SYMMETRY NEEDLE HEPARIN NEEDLE GEA SYMMETRY SURGICAL, INC 086

    Patients

    Seq Age Sex Outcome Treatment
    1