BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11692036 · Received April 20, 2021

    Report

    Report Number
    8010047-2021-05143
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. DURING THE PREPARATION OF THE SMALL MESH, THE REPORTED ERROR AND THE MALFUNCTION OCCURRED, EVEN BEFORE THE START. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. DURING THE PREPARATION OF THE SMALL MESH, THE REPORTED ERROR AND THE MALFUNCTION OCCURRED, EVEN BEFORE THE START. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE SUCCESSFULLY. THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY, A PART OF THE TISSUE PAD WAS PEELED AWAY. THE COATING OF THE PROBE WAS PARTIALLY PEELING. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, OMSC PRESUMES THAT THE EVENT OCCURRED DUE TO THE FOLLOWING OCCURRENCE MECHANISM. 1) THE TISSUE PAD WAS WORN AWAY BECAUSE NO TISSUE WAS BEING GRASPED BETWEEN THE GRASPING SECTION AND THE PROBE TIP WHEN THE DEVICE WAS ACTIVATED OUTPUT IN SEAL & CUT MODE FOR/AFTER A TRANSECTION OF TISSUE. 2) THE TISSUE PAD WAS EXCESSIVELY HEATED DUE TO FRICTION BETWEEN THE GRASPING SECTION AND THE PROBE TIP. THIS CAUSED THE TISSUE PAD TO BE PARTIALLY PEELED AWAY. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING A STANDARD OPERATION USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. INSULATING LAYER ON THE BRANCHES CAME OFF ON 2 SCISSORS. AN UNSPECIFIED ERROR OCCURRED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS PROVIDED. ON MARCH 26, 2021, IT WAS FOUND THAT "INSULATING LAYER ON THE BRANCHES" WAS THE TISSUE PAD. THIS IS THE SECOND ONE OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591635 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR109375

    Patients

    Seq Age Sex Outcome Treatment
    1