BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL EYE TRAY

    MDR report key: 7829401 · Received August 29, 2018

    Report

    Report Number
    1417592-2018-00083
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    July 12, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    PZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT, WHILE UNDERGOING A STRABISMUS SURGERY, BILATERAL LATERAL RECTUS RECESSION, THE FORCEPS HOLDING ONTO THE TISSUE POPPED OPEN AND FELL TO THE FLOOR. THE FORCEPS THAT FELL WERE NO USED AGAIN THROUGHOUT THE PROCEDURE; HOWEVER THE EVENT DID RESULT IN A DELAY IN THE PROCEDURE THAT REQUIRED ADDITIONAL ANESTHESIA TO BE ADMINISTERED. THE PATIENT MADE A FULL RECOVERY WITH NO FURTHER INCIDENT REPORTED. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY, AS A RESULT OF THE INCIDENT. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE CUSTOMER REPORTED ISSUE WAS NOT CONFIRMED. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR ADDITIONAL ANESTHESIA THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    LOCKING FORCEPS WOULD NOT HOLD ONTO TISSUE RESULTING IN FORCEPS POPPING OFF IN THE MIDDLE OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669154 SURGICAL EYE TRAY PZG MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other