BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MON-A-THERM

    MDR report key: 1033372 · Received April 23, 2008

    Report

    Report Number
    2936999-2008-00186
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    September 1, 2007
    Report Date
    March 27, 2008
    Product Code
    BZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED CALLS HAVE BEEN MADE TO THE HOSPITAL TO GAIN FURTHER INFO INCLUDING A LOT NUMBER AND TO DETERMINE IF THIS INCIDENT WAS PREVIOUSLY REPORTED BY OTHER STAFF MEMBER(S) IN 2007. IN 2007, A SIMILAR CALL WAS RECEIVED FROM AN ANESTHESIA NURSE REPORTING TO BE FROM THE SAME HOSPITAL. THE NURSE REPORTED THE END USER (A SURGEON) WAS WORKING IN THE SAME AREA AS THE ESOPHAGUS DURING AN OPERATIVE PROCEDURE. DURING THE PROCEDURE THE PT DEVELOPED A PERFORATION OF THE ESOPHAGUS, HOWEVER, IT WAS NOT CAUSED BY THE ESOPHAGEAL STETHOSCOPE. NO OTHER INFO WAS PROVIDED. FOLLOW-UP CALLS WERE MADE TO THE HOSPITAL AND WE REQUESTED THE ESOPHAGEAL STETHOSCOPE BE RETURNED FOR OUR EVAL. NO DEVICE WAS RETURNED. A LOT NUMBER WAS PROVIDED AND THE MFR'S REVIEW FOUND NO NONCONFORMANCE FOR THE LOT. IN RESPONSE TO THIS RECENT CALL, WE MADE SEVERAL ATTEMPTS TO CONTACT THE HOSPITAL ANESTHESIA AND RISK MANAGEMENT AND THERE HAS BEEN NO RESPONSE. ALTHOUGH AT THIS TIME WITHOUT A LOT NUMBER, OR ADD'L INFO FROM STAFF WE CAN NOT BE ABSOLUTELY CERTAIN THIS RECENT REPORTED INFO IS A DUPLICATE, HOWEVER, WE BELIEVE IT IS. IF WE RECEIVED ANY NEW SIGNIFICANT INFO FROM THE HOSPITAL, OR THE DEVICE IS RETURNED FOR OUR INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A REQUEST FOR PRODUCT INFO THE CALLER STATED THAT IN 2007 A STAFF CRNA WAS DOING A CASE CERVICAL DISCECTOMY. THEY NOTICED THE TIP OF THE PROBE IN THE SURGICAL SPACE. THE CASE WAS DISCONTINUED AND A THORACIC SURGEON CAME IN AND STATED THERE WAS A LINEAR TEAR IN THE ESOPHAGUS AND REPAIRED THE TEAR. CERVICAL AREA WAS CLOSED AND PT RETURNED TO FLOOR. THE CALLER STATED PT IS DOING FINE AND PT HAD COMPLETED DISCECTOMY IN LATER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MON-A-THERM ESOPHAGEAL STETHOSCOPE W/TEMP BZW EST18FR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention