BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 20CM FRONT-ACTUATED GRIP

    MDR report key: 6191955 · Received December 20, 2016

    Report

    Report Number
    8010047-2016-01539
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    October 6, 2016
    Report Date
    December 21, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC IMPLEMENTED THE EVALUATION ON NOVEMBER 22, 2016. WHEN WE IMPLEMENTED PROBE CHECK, THE PROBE DAMAGE ERROR WAS NOT REPRODUCED. WHEN WE CLOSED THE GRASPING SECTION AND ACTIVATED SEAL MODE, SHORT CIRCUIT ERROR WAS NOT OCCURRED. THE COATING ON THE OUTER SURFACE OF THE JAW WAS WORN AND PARTIALLY CAME OFF. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. THESE TYPES OF COATING DAMAGE AND ERROR ARE MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE COATING PARTIALLY CAME OFF WHEN THE DEVICE WAS SCRAPED BY OTHER HARD INSTRUMENT. THERE IS A POSSIBILITY THAT THE PROBE DAMAGE ERRORS OCCURRED BY EXCESSIVE LOADS ON THE PROBE, DUE TO CONTACTING THE PROBE WITH HARD OBJECTS SUCH AS OTHER INSTRUMENTS EXCESSIVELY. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY STATES. WARNINGS: IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS FILTHY DURING TREATMENT, WIPE IT WITH A SOFT OBJECT SUCH AS A PIECE OF GAUZE OR A BRUSH. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL OR THE TIP OF TWEEZERS. OTHERWISE, THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT, THE FLUORINE RESIN PART, A COATED SURFACE OR THE PROBE TIP MAY BE SCRATCHED AND DAMAGED, WHICH MAY LEAD TO FALL-OFF OF THE DAMAGED PART INTO THE BODY CAVITY OR BURNS OF THE TISSUE BY A HIGH-FREQUENCY LEAK CURRENT OUTPUT DUE TO DESTRUCTION OF THE INSULATION STRUCTURE. WARNINGS: 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.

    Description of Event or Problem · 1

    THE THREE SUBJECT DEVICES, ONE TB-0009OF AND TWO TB-0520FCS, WERE USED DURING A NECK DISSECTION AND A PARTIAL MAXILLECTOMY. THE PROBE OF THE FIRST DEVICE, TB-0009OF, FELL OFF INTO THE PATIENT BODY. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT BODY. ALTHOUGH THE FIRST DEVICE WAS REPLACED TO THE TWO TB-0520FCS, BOTH OF THE DEVICES APPEARED PROBE DAMAGE ERRORS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE THREE SUBJECT DEVICES WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION ON NOVEMBER 22, 2016 CONFIRMED THAT THE COATING ON THE OUTER SURFACE OF THE JAW OF ONE OF THE TB-0520FCS WAS WORN AND PARTIALLY PEELED. THIS MDR IS REGARDING THE COATING DAMAGE OF THE TB-0520FC. PLEASE CROSS-REFERENCE THE FOLLOWING REPORT REGARDING THE PROBE DAMAGE OF THE TB-0009OF: 8010047-2016-10037.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840876 THUNDERBEAT 5MM 20CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0520FC 62K

    Patients

    Seq Age Sex Outcome Treatment
    1