BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT

    MDR report key: 8093257 · Received November 20, 2018

    Report

    Report Number
    8010047-2018-02232
    Event Type
    Injury
    Date Received
    November 20, 2018
    Report Date
    November 21, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE AUTHOR HAS NOT PROVIDED ADDITIONAL INFORMATION ABOUT INDIVIDUAL CASES. SINCE THE LOT NO. IS UNKNOWN, THE MANUFACTURING HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES WHICH PASSED THE INSPECTION. FROM THE REPORTED INFORMATION, WE PRESUME THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO THE MALFUNCTION OF THE DEVICE, BUT OCCURRED AS "A" GENERAL "COMPLICATIONS" OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED AT THE JAPAN DIGESTIVE DISEASE WEEK 2018; DIGITAL POSTER SESSIONS OF DIGESTIVE SURGERY - 435. ARTICLE TITLE: "INVESTIGATION OF POSTOPERATIVE RECURRENT NERVE PARALYSIS RISK FACTORS IN SUBTOTAL ESOPHAGECTOMY." SUMMARY: DURING THE SUBTOTAL ESOPHAGECTOMY WHICH WERE PERFORMED BETWEEN JUNE 2013 AND DECEMBER 2017, THREE TYPES OF EQUIPMENT WERE USED. ONE OF THEM WAS THE ULTRASONIC SURGICAL DEVICE "WHICH" NAME WAS THUNDERBEAT. THE TOTAL NUMBER OF PATIENTS WERE 99. IN THIS RETROSPECTIVE STUDY, IT WAS REPORTED AS FOLLOWS: RECURRENT NERVE PARALYSIS DEVELOPED IN 33 PATIENTS AFTER SURGERY. THERE WAS NO REPORT OF ADDITIONAL TREATMENT IN ALL CASES. THIS IS THE REPORT REGARDING RECURRENT NERVE PARALYSIS FOR THUNDERBEAT. IT'S HIGHLY LIKELY THAT THE MODEL NUMBER IS TB-0535FCS ON THE BASIS OF THE DELIVERY RECORD. BUT THE MODEL NUMBER COULD NOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930922 THUNDERBEAT ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other