BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 11996844 · Received June 14, 2021

    Report

    Report Number
    8010047-2021-07513
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    December 7, 2020
    Report Date
    June 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. BOTH OF THE LOT NUMBERS WERE THE SAME(KR910700). THIS IS THE SECOND ONE OF TWO REPORTS. THE TISSUE PAD IN THE GRASPING SECTION WAS MISSING. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE TISSUE PAD WAS DAMAGED SINCE THE USER CONTINUED TO ACTIVATE OUTPUT WITHOUT GRASPING TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT). THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING A LAPAROSCOPIC SUBTOTAL COLECTOMY USING THE DEVICES, THE FOLLOWING EVENT OCCURRED. THE FIRST DEVICE HAD A MALFUNCTION. THE DEVICE WAS CHANGED TO THE SECOND DEVICE BUT AN UNSPECIFIED ERROR CONTINUED. BROKEN PARTS WERE RETRIEVED FROM THE PATIENT LAPAROSCOPICALLY. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON MAY 24, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892888 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR910700 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1