BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL ESOPHAGEAL STETHOSCOPE 400 SERIES

    MDR report key: 1571683 · Received December 28, 2009

    Report

    Report Number
    9613793-2009-00001
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    July 21, 2009
    Report Date
    August 3, 2009
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    BZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY WAS CONTACTED AND SENT THE INCIDENT DEVICE FOR INVESTIGATION. EXTENSIVE RESEARCH WAS CONDUCTED IN ORDER TO CONFIRM NO MANUFACTURING ERRORS CONTRIBUTED TO THIS INCIDENT. THE DEVICE MET ALL SPECIFICATIONS IN PLACE FOR THE DEVICE. PRODUCTION PROCESSES WERE CHECKED AND VERIFIED TO HAVE BEEN EFFECTIVELY FOLLOWED BY MANUFACTURING PERSONNEL. IN ADDITION TO A PULL TEST FOR BREAKING POINT, THICKNESS PARAMETERS WERE DETERMINED TO BE CORRECT AS WELL. ALL PRODUCTION RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO DISCREPANCIES NOTED DURING FINAL INSPECTION. THE ROOT CAUSE OF THE PROBLEM EXPERIENCED COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE ANESTHESIOLOGIST NOTICED THE PATIENT'S TEMPERATURE DROPPING DURING A PROCEDURE AND A SECOND ESOPHAGEAL STETHOSCOPE 400 SERIES 18FR WAS INSERTED. THEY WERE LABELED #1 AND #2 RESPECTIVELY. AT THE END OF THE PROCEDURE, WHEN BOTH TEMPERATURE PROBES WERE REMOVED, ONE HAD A SHEATH AND ONE DID NOT. THE ANESTHESIOLOGIST CHECKED THE PATIENT'S MOUTH AND HYPOPHARYNX FOR THE SHEATH, BUT IT WAS NOT THERE. A SURGEON CAME IN AND DID AN ESOPHAGOSCOPY AND PICKED THE SHEATH OUT WITH GRABBERS. THE PATIENT WAS ON THE OPERATING ROOM TABLE AN EXTRA 20-30 MINUTES FOR THE SHEATH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL ESOPHAGEAL STETHOSCOPE 400 SERIES ESOPHAGEAL STETHOSCOPE BZT DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention