BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION TRANSILLUMINATION SYSTEM

    MDR report key: 9972231 · Received April 17, 2020

    Report

    Report Number
    2183446-2020-00001
    Event Type
    Injury
    Date Received
    April 17, 2020
    Date of Event
    January 7, 2020
    Report Date
    April 16, 2020
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FDG
    PMA / PMN Number
    K964561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DETACHED TIP WAS LOCATED IN THE PATIENT'S ESOPHAGUS AND RETRIEVED BEDSIDE AFTER COMPLETION OF A NISSEN FUNDOPLICATION. THE DEVICE LABELING INDICATES THAT THE TIP CAN COME DETACHED FROM THE CABLE IF THE TIP IS BENT AT A SIGNIFICANT ANGLE DURING EXTUBATION. THE DEVICE HISTORY RECORD OF THE PRODUCTION LOT WAS REVIEWED AND NO ISSUES WERE RECORDED. THE RETURNED BOUGIE TIP WAS EXAMINED AND NO MANUFACTURING DEFECTS WERE FOUND. THE MANUFACTURER ALSO REVIEWED COMPLAINT TRENDING REPORTS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER. ADDITIONALLY, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS SIZE/MODEL OF DEVICE. BASED ON A REVIEW OF THE TRENDING REPORTS AND THE INFORMATION AVAILABLE, THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. DIVERSATEK HEALTHCARE HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT, AND THEREFORE, NO FUTURE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    PER SUS VOLUNTARY EVENT REPOT / MEDWATCH REPORT MW5093628) FROM (B)(6): THE TIP OF THE LIGHTED BOUGIE WAS RETAINED IN A PT'S ESOPHAGUS FOLLOWING REMOVAL OF A LIGHTED BOUGIE. THE LIGHTED BOUGIE WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE AND THE SEPARATION OF THE TIP WAS NOT RECOGNIZED. ON THE MORNING FOLLOWING SURGERY, PT COMPLAINED OF NAUSEA, VOMITING AND A PAIN SCORE OF 12/10. FOREIGN OBJECT IDENTIFIED IN THE POSTERIOR ORAL PHARYNX AND REMOVED AT BEDSIDE WITH FORCEPS. FOREGIN OBJECT IDENTIFIED AS THE DISPOSABLE TIP OF A LIGHTED BOUGIE. PERMANENT HARM WAS NOT ASSESSED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437608 INNERVISION TRANSILLUMINATION SYSTEM LIGHTED BOUGIE, PRODUCT CODE: FDG FDG DIVERSATEK HEALTHCARE 1465-40 222548

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention