BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGI-TIP TRANSDUCER COVER

    MDR report key: 6543746 · Received May 4, 2017

    Report

    Report Number
    1937223-2016-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    June 28, 2016
    Report Date
    July 28, 2016
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC
    Product Code
    ITX
    PMA / PMN Number
    K013721
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT WAS NOT AVAILABLE FOR REVIEW BY CIVCO. TEN COVERS FROM THE SAME LOT AND BOX WERE RETURNED FROM THE FACILITY AND ALL WERE TESTED FOR LEAKS AND TEARS UNDER SIMULATED CONDITIONS. NO SAMPLES TORE OR LEAKED UNDER SIMULATED USAGE. WE HAVE REVIEWED THE INCOMING INSPECTION RECORDS FOR THE COMPONENTS USED IN THE COVER ASSEMBLY AND THERE WERE NO ANOMALIES NOTED IN THE DHR. ADDITIONALLY, THE MANUFACTURING RECORDS FOR THE LOT IN QUESTION WERE ALSO REVIEWED. ALL RECORDS SHOW THE PRODUCT HAS PASSED ALL INCOMING AND IN-PROCESS INSPECTION AND EVALUATIONS. WE HAVE BEEN UNABLE TO OBTAIN FURTHER INFORMATION FROM THE USER AT THIS TIME TO DETERMINE IF THERE WERE ANY EXTERNAL OPPORTUNITY FOR THE COVER AND PROBE TO CONTACT A SHARP INSTRUMENT OR OBJECT WHICH COULD CAUSE THE COVER TO TEAR WHEN IT IS UNDER TENSION. THIS IS A RE-SUBMISSION OF THE REPORT CONDUCTED ON 7/28/2016. ORIGINAL SUBMISSION HAD INCORRECT FACILITY IDENTIFICATION NUMBER AND WAS REJECTED. FAILED DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CIVCO WAS NOTIFIED ON (B)(4) 2016 BY THE USER FACILITY OF A COVER RIPPING DURING A LAMINOPLATY PRODUCTURE AND CONTAMINATED THE STERILE FIELD. CUSTOMER STATED THE COVERS WERE HELD IN A TEMPERATURE CONTROLLED CABINET AND WOULD BE SENDING BACK 10 SAMPLES FOR REVIEW. ON 7/20/2016 CIVCO RECEIVED A COPY OF THE REPORT SUBMITTED BY THE CUSTOMER FURTHER DETAILING THE EVENT THAT A CHILE WAS UNDERGOING A LAMINOPLASTY PROCEDURE. AFTER INITIAL FIRST INCISION, THE TRANSDUCER COVER WAS USED IN THE STERILE PROCEDURE TO COVER THE ULTRASOUND PROBE. ONCE THE ULTRASOUND PROBE WITH COVER WAS PLACED ON THER STERILE FIELD, THE RUBBER PART OF THE COVER BROKE. THE PROBE WAS IDENTIFIED TO BE NON-STERILE AND WAS IN THE SURGICAL SITE. THE DOCTOR STOPPED THE PROCEDURE, TOOK A CULTOR OF THE WOUND, AND VANCOMYCIN POWDER WAS PLACED ON THE INCISION. THE INCISION WAS CLOSED. THE DOCTOR HAD NOT ENTERED THE DURA AT THE TIME THE BREACH WAS DISCOVERED. THE PATIENT WAS DISCHARGED WITH ANTIBIOTICS AND IS TO RETURN IN 3-4 WEEKS FOR LAMINOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325174 SURGI-TIP TRANSDUCER COVER ULTRASOUND TRANSDUCER COVER ITX CIVCO MEDICAL INSTRUMENTS CO., INC 610-833 M941840

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other