BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9640205 · Received January 28, 2020

    Report

    Report Number
    8010047-2020-01038
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Report Date
    March 30, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTARY REPORT TO CORRECT THE INFORMATION ON THE LOT NUMBER. THE LOT NUMBER OF THE SUBJECT DEVICE WAS ¿KR869853¿ NOT ¿KR871300¿.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 15.5 MM FROM THE DISTAL END. THERE WAS SCRATCH ON THE PROBE. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED FROM THE SCRATCH. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE PROBE WAS CRACKED WHEN THE USER ACTIVATED OUTPUT CONTACTING WITH METAL OR SOMETHING HARD OBJECT SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS, BESIDES THE PROBE WAS BROKEN OFF WHEN THE PROBE WAS SUBJECTED TO A LOAD. THE ABOVE DEVICE HANDLING HAS BEEN WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. DO NOT GRASP OR LET THE PROBE TIP CONTACT HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR). ALSO, BE CAREFUL TO AVOID CONTACTING THE PROBE TIP WITH THOSE ACCIDENTALLY. PARTICULARLY DURING ACTIVATION, A SCRATCH ON THE PROBE TIP COULD OCCUR DUE TO ULTRASONIC VIBRATION, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY. IN ADDITION, THE HIGH-FREQUENCY (RF BIPOLAR) CURRENT FLOWS THROUGH THE METAL AND GENERATES SPARK DISCHARGE, WHICH MAY CAUSE BURNS AND DECREASE FUNCTIONALITIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING AN OESOPHAGECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE TIP OF THE SUBJECT DEVICE BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100319 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR869853 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1