BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION TRANSILLUMINATION SYSTEM

    MDR report key: 8932030 · Received August 26, 2019

    Report

    Report Number
    2183446-2019-00001
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    April 19, 2019
    Report Date
    August 19, 2019
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FDG
    PMA / PMN Number
    K964561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A ROUTINE MANUFACTURER REVIEW OF THE ONLINE FDA MAUDE DATABASE, MANUFACTURER DISCOVERED REPORT MW5086352. THIS REPORT WAS NEVER MADE TO THE MANUFACTURER. THE REPORT DID NOT CONTAIN ANY INFORMATION IDENTIFYING THE CUSTOMER/USER FACILITY, SO THE MANUFACTURER WAS NOT ABLE TO PERFORM A COMPLETE INVESTIGATION. THE REPORT STATES: "RETAINED BOUGIE TIP REQUIRING SURGICAL INTERVENTION TO REMOVE DUE TO USING AGAINST MFR'S RECOMMENDATIONS". THE DEVICE LABELING INDICATES THAT THE TIP CAN COME DETACHED FROM THE CABLE IF THE TIP IS BENT AT A SIGNIFICANT ANGLE WITHIN THE PATIENT. THE DEVICE HISTORY RECORD OF THE PRODUCTION LOT WAS REVIEWED AND NO ISSUES WERE RECORDED. THE MANUFACTURER ALSO REVIEWED COMPLAINT TRENDING REPORTS. NO OTHER COMPLAINTS WERE RECEIVED ON THIS PRODUCTION LOT. BASED ON A REVIEW OF 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 FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING A ROUTINE REVIEW OF THE FDA MAUDE DATABASE, MANUFACTURER DISCOVERED EVENT REPORTED ON DEVICE THAT WAS NOT REPORTED TO MANUFACTURER. PER MW5086352, "RETAINED BOUGIE TIP REQUIRING SURGICAL INTERVENTION TO REMOVE DUE TO USING AGAINST MFR'S RECOMMENDATIONS". THIS IS THE ONLY KNOWN INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724336 INNERVISION TRANSILLUMINATION SYSTEM LIGHTED BOUGIE FDG DIVERSATEK HEALTHCARE 1465-50 222549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention