BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP ESOPHAGEAL STETHOSCOPE, 18FR

    MDR report key: 220837 · Received April 19, 1999

    Report

    Report Number
    2020364-1999-00002
    Event Type
    Other
    Date Received
    April 19, 1999
    Date of Event
    February 23, 1999
    Report Date
    April 16, 1999
    Manufacturer
    SIMS/RESPIRATORY SUPPORT PRODUCTS
    Product Code
    BZW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, A 66 YR OLD MALE PT (WEIGHT APPROX 220 LBS) DEVELOPED AN ESOPHAGEAL RUPTURE 3 DAYS AFTER UNDERGOING A RADICAL PROSTATECTOMY, THE RUPTURE WAS DISCOVERED ON AN X-RAY 3 DAYS AFTER SURGERY WHEN THE PT DEVELOPED SEVERE SHORTNESS OF BREATH AND HIS "O2 SATURATION HAD DROPPED". THE RUPTURE WAS THORACICALLY REPAIRED. WHEN QUESTIONED AS TO WHETHER OR NOT THE PT MAY HAVE HAD A WEAKNESS IN THE ESOPHAGUS PRIOR TO THE ESOPHAGEAL STETHOSCOPE BEING USED, THE CERTIFIED REGISTERED NURSE ANESTHETIST STATED, "DURING THE THORACIC SURGERY TO REPAIR THE RUPTURE, IT WAS OBSERVED THAT THE PT HAD AN INFLAMED ESOPHAGUS AND A HIATAL HERNIA." THE RUPTURE WAS IN AN UP AND DOWN CONFIGURATION (NOT ACROSS THE ESOPHAGUS). THE SIZE OF THE RUPTURE IS UNREPORTED. THE PT RECOVERED NICELY AND WAS RELEASED FROM THE HOSP. THE CERTIFIED REGISTERED NURSE ANESTHETIST STATED THE ORIGIN OF THE ESOPHAGEAL RUPTURE IS UNK. THE ESOPHAGEAL STETHOSCOPE WAS DISCARDED AFTER THE FIRST SURGERY. THE LOT NUMBER IS UNREPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP ESOPHAGEAL STETHOSCOPE, 18FR ESOPHAGEAL STETHOSCOPE, 18FR BZW SIMS/RESPIRATORY SUPPORT PRODUCTS VES400-18 UNREPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other