BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3760922 · Received April 9, 2014

    Report

    Report Number
    8010047-2014-00130
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 17MM FROM THE DISTAL END. AND THERE WAS A SCRATCH AT THE BROKEN POINT. THE PTFE PAD WAS NOT WORN OUT. THE PHYSICIAN ACTIVATED THE OUTPUT WITH TWISTING THE SHAFT AND GRASPING THE TISSUE AT THE TIP OF THE PROBE, THEN THE PROBE AND GRASPING SECTION BECAME CONTACT EACH OTHER. IT FOLLOWED THAT THE CONTACT MARK WAS MADE ON THE JAW AND THE PROBE. IT WAS CONSIDERED THE POSSIBLE REASON OF THE PROBE DAMAGE ERROR AND THE ALARM. 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 ABOVE HANDLING HAS ALREADY BEEN RESTRICTED ON THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. 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 COLECTOMY WITH THE USE OF THE TB-0535FC TH ALARM HAD OCCURRED THEN THE PROBE TIP HAD BROKEN AND FALLEN OFF INTO THE PATIENT'S CAVITY. THE PHYSICIAN HAD RETRIEVED THE FRAGMENT BY THE UNSPECIFIED GRASPING FORCEPS AND RE-STARTED THE PROCEDURE USING OTHER DEVICE. 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
    213241 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3X04

    Patients

    Seq Age Sex Outcome Treatment
    1