BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSHIBA

    MDR report key: 5082697 · Received September 16, 2015

    Report

    Report Number
    2020563-2015-00003
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    August 3, 2015
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS BEING SUBMITTED IN RESPONSE TO THE MEDWATCH REPORT SUBMITTED BY THE CUSTOMER ((B)(4)). THIS REPORT WAS RECEIVED ON AUGUST 3, 2015 FROM FDA. IT HAS BEEN DETERMINED THAT A SMALL SLIT OR TEAR WAS CAUSED BY CONTINUED HANDLING AND USE OF THE PROBE. WHEN THE PROBE IS CLEANED IT IS SOAKED IN A DISINFECTANT BATH. THE LEAKING FLUID IS THE DISINFECTANT SOLUTION THAT PERMEATED INTO THE PROBE THROUGH THE TEAR AND DEPENDING ON HOW IT IS HUNG TO DRY OR HELD THE SOLUTION WILL LEAK OUT THROUGH THE TEAR. THE POSSIBILITY OF THIS TYPE OF FAILURE IS A KNOWN RISK AND USER INFORMATION INCLUDES INSTRUCTIONS FOR VISUAL INSPECTION BEFORE AND AFTER USE.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE MANUFACTURER SHOWS THAT THE CROSS SECTION OF THE SLIT FOUND NEAR THE TRANSDUCER HEAD IS SMOOTH AND THEREFORE MOST PROBABLY MADE BY A SHARP OBJECT WHEN HANDLING THE TRANSDUCER. THE POSSIBILITY OF THIS TYPE OF FAILURE IS A KNOWN RISK AND USER INFORMATION IN THE OPERATION MANUAL INCLUDES INSTRUCTIONS FOR INSPECTION (VISUALLY AND ELECTRICALLY) BEFORE AND AFTER USE. THE MANUFACTURER BELIEVES THAT THE CUSTOMER DID NOT USE THE TRANSDUCER IN ACCORDANCE WITH THE OPERATION MANUAL.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WILL INVESTIGATE THIS FAILED TRANSDUCER.

    Description of Event or Problem · 1

    FOLLOWING USE, A TOSHIBA PET-512MC TEE PROBE WAS CLEANED IN CIDEX OPA. ACCORDING TO THE MEDWATCH REPORT SUBMITTED BY THE CUSTOMER, AFTER THE CLEANING PROCESS A SMALL PUNCTURE WITH CLEAR LIQUID DRAINING OUT OF IT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610960 TOSHIBA ULTRASONIC DIAGNOSTIC TRANSDUCER ITX TOSHIBA MEDICAL SYSTEMS CORPORATION PET-512MC

    Patients

    Seq Age Sex Outcome Treatment
    1