BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3850755 · Received March 20, 2014

    Report

    Report Number
    8010047-2014-00095
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 18MM FROM THE DISTAL END, AND THERE WAS A SCRATCH AT THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THE PTFE PAD WAS NOT WORN OUT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THERE WAS THE POSSIBILITY THAT THE PHYSICIAN ACTIVATED THE OUTPUT WITH OPENING THE GRASPING SECTION OR WITHOUT GRASPING THE TISSUE. IT WAS CONSIDERED THE POSSIBLE REASON OF THE OPEN CIRCUIT ERROR. AS THE RESULT OF EVALUATION, WE HAVE CONCLUDED THAT THE PROBE TIP PRESUMABLY WAS SCRATCHED BECAUSE THE PHYSICIAN ACTIVATED SEAL AND CUT MODE OUTPUT WHILE THE PROBE TIP WAS IN CONTACT WITH METAL SUCH AS A CLIP AND FORCEPS. IT WAS CONSIDERED THE POSSIBLE REASON OF THE PROBE DAMAGE ERROR. AFTER THAT, SINCE THE PHYSICIAN CONTINUED TO USE THE DEVICE, A CRACK OF THE PROBE WAS OCCURRED AND THE PROBE PRESUMABLY BROKE OFF DUE TO THE STRESS BY EXCESSIVE FORCE. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THE INSTRUCTION MANUAL OF THUNDERBEAT MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE LAPAROSCOPIC TOTAL GASTRIC RESECTION WITH THE USE OF THE TB-0535FC, THE OPEN CIRCUIT ERROR HAD OCCURRED. THE FACILITY HAD CHANGED THE TRANSDUCER INTO ANOTHER ONE, IT HAD BEEN NO PROBLEM FOR A WHILE, BUT THEN THE OPEN CIRCUIT ERROR HAD OCCURRED TWICE. AFTER THE TWO HOURS OF THE START OF THE PROCEDURE, THE PROBE DAMAGE ERROR HAD OCCURRED, HOWEVER THE PHYSICIAN HAD CONTINUED TO USE THE TB-0535FC THEN THE PROBE TIP HAD BROKEN AND FALLEN OFF INTO THE PATIENT'S CAVITY. THE PHYSICIAN HAD RE-STARTED THE PROCEDURE USING OTHER DEVICE AND THE PROCEDURE HAD BEEN COMPLETED. THERE WAS NO REPORT OF THE PATIENT'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167157 THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC K3920

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR