BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION TRANSILLUMINATION SYSTEM

    MDR report key: 7820278 · Received August 27, 2018

    Report

    Report Number
    2183446-2018-00001
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    May 16, 2018
    Report Date
    August 2, 2018
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FDG
    UDI-DI
    00816734021293
    PMA / PMN Number
    K964561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A TEAR OF THE ESOPHAGUS AFTER THE DISPOSABLE TIP DETACHED FROM THE DEVICE. THE TEAR WAS REPAIRED THROUGH ENDOSCOPIC INTERVENTION. THE CUSTOMER BELIEVES THE TIP FOLDED BACK ON ITSELF DURING PASSAGE THROUGH THE ESOPHAGUS. THE DEVICE LABELING INDICATES THAT THE TIP CAN COME DETACHED IF THE TIP IS BENT AT A SIGNIFICANT ANGLE WITHIN THE PATIENT. DISPOSABLE TIPS FROM THE SAME MANUFACTURING LOT WERE EXAMINED AND ALL SPECIFICATIONS WERE WITHIN TOLERANCES. ADDITIONALLY, THE DEVICE HISTORY RECORD OF THE MANUFACTURING LOT WAS REVIEWED AND NO ISSUES WERE RECORDED. THE MANUFACTURER ALSO REVIEWED COMPLAINT TRENDING REPORTS. NO SIMILAR ISSUES HAVE BEEN REPORTED IN ANY COMPLAINT TRENDS. THEREFORE, THE MANUFACTURER BELIEVES THIS TO BE AN ISOLATED INCIDENT. THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. DIVERSATEK HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON MW5078295 THE 50FR BOUGIE TIP BECAME DISLODGED FROM THE ILLUMINATION CORD IN THE PATIENT'S ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658612 INNERVISION TRANSILLUMINATION SYSTEM LIGHTED BOUGIE FDG DIVERSATEK HEALTHCARE 1465-50 221575 00816734021293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention