BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPH STETH 400 SERIES 18 FR, 400 SERIES

    MDR report key: 19929636 · Received August 7, 2024

    Report

    Report Number
    9613793-2023-00002
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    January 1, 2016
    Report Date
    March 6, 2023
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    BZT
    UDI-DI
    00749756045988
    PMA / PMN Number
    K193027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS FOUND IN THE LITERATURE SOURCE "ARYTENOID DISLOCATION AFTER UNEVENTFUL ENDOTRACHEAL INTUBATION: A CASE REPORT" FROM THE JOURNAL CALLED KOREAN J ANESTHESIOL REPORTING, "ON THE FIRST POSTOPERATIVE DAY IN THE WARD, SHE COMPLAINED OF MODERATE HOARSENESS. THE PHYSICIAN EXPECTED THE SYMPTOM WOULD RESOLVE SPONTANEOUSLY, BUT THE PATIENT COMPLAINED OF PERSISTENT HOARSENESS ON THE FOURTH DAY AFTER THE OPERATION. THERE WERE NO SYMPTOMS OTHER THAN HOARSENESS. ON THE SIXTH DAY AFTER THE OPERATION, FIBER-OPTIC LARYNGOSCOPY WAS PERFORMED BY THE LARYNGOLOGIST. ON LARYNGOSCOPY, THE LEFT VOCAL CORD WAS FIXED IN THE PARAMEDIAN POSITION, HOWEVER MINIMAL MOVEMENT OF ARYTENOID DURING PHONATION WAS OBSERVED. ARYTENOID DISLOCATION WAS SUSPECTED, AND SURGICAL REDUCTION UNDER GENERAL ANESTHESIA WAS PERFORMED. THE PATIENT'S VOICE WAS IMPROVED IMMEDIATELY AFTER THE SURGERY; AND A MONTH AFTER THE SURGERY, MOVEMENT OF THE VOCAL CORDS WAS COMPLETELY NORMAL." (B)(4). THE FAILURE MODE EFFECT ANALYSIS (FMEA) WAS REVIEWED AND UPDATED TO REFLECT THIS RISK. DEROYAL ALSO REVIEWED THE MATERIAL REVIEW REPORT (MRR'S) AND IT WAS CONFIRMED THAT THERE WERE NO OTHER MRR'S RELATED TO THIS PRODUCT UNDER INVESTIGATION. THIS COMPLAINT WAS FOUND IN LITERATURE AND NO CONTACT INFORMATION WAS PROVIDED THEREFORE NO FOLLOW-UPS WERE ABLE TO BE CONDUCTED DUE TO THE SOURCE. WHILE NO SPECIFIC CORRECTIVE OR PREVENTATIVE ACTIONS WERE TAKEN, DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON THE FIRST POSTOPERATIVE DAY IN THE WARD, SHE COMPLAINED OF MODERATE HOARSENESS. THE PHYSICIAN EXPECTED THE SYMPTOM WOULD RESOLVE SPONTANEOUSLY, BUT THE PATIENT COMPLAINED OF PERSISTENT HOARSENESS ON THE FOURTH DAY AFTER THE OPERATION. THERE WERE NO SYMPTOMS OTHER THAN HOARSENESS. ON THE SIXTH DAY AFTER THE OPERATION, FIBER-OPTIC LARYNGOSCOPY WAS PERFORMED BY THE LARYNGOLOGIST. ON LARYNGOSCOPY, THE LEFT VOCAL CORD WAS FIXED IN THE PARAMEDIAN POSITION, HOWEVER MINIMAL MOVEMENT OF ARYTENOID DURING PHONATION WAS OBSERVED. ARYTENOID DISLOCATION WAS SUSPECTED, AND SURGICAL REDUCTION UNDER GENERAL ANESTHESIA WAS PERFORMED. THE PATIENT'S VOICE WAS IMPROVED IMMEDIATELY AFTER THE SURGERY; AND A MONTH AFTER THE SURGERY, MOVEMENT OF THE VOCAL CORDS WAS COMPLETELY NORMAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560417 ESOPH STETH 400 SERIES 18 FR, 400 SERIES STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS BZT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L 81-040418 00749756045988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention