BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9325845 · Received November 15, 2019

    Report

    Report Number
    8010047-2019-03980
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 2, 2019
    Report Date
    January 29, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO CORRECT INFORMATION ON D4 AND PROVIDE ADDITIONAL INFORMATION. THE LOT NUMBER OF THE SUBJECT DEVICE WAS "KR844447", NOT "KR844389". THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 19 MM FROM THE DISTAL END. THERE WAS NO SCRATCH ON THE PROBE. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED. THE PROBE TURNED BLACK AROUND THE BROKEN POINT. THE COATING FOR ELECTRIC INSULATION OF THE GRASPING SECTION WAS PARTIALLY MISSING. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE CRACK OCCURRED ON THE PROBE SINCE THE LOAD SUCH AS SPARKS WAS APPLIED TO THE PROBE. THE CRACK DEVELOPED WHEN THE USER OUTPUT THE DEVICE OR GRASPED THE TISSUE, AND THE PROBE BROKE OFF. IT WAS ALSO KNOWN THAT THE COATING FOR ELECTRIC INSULATION OF THE GRASPING SECTION WAS DAMAGED WHEN THE USER SCRAPED TISSUE OR COAGULUM ON THE GRASPING SECTION WITH A SHARP INSTRUMENT. THE ABOVE DEVICE HANDLING HAS BEEN WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. *SHOULD ANY IRREGULARITY (ERROR WINDOW, ABNORMAL NOISE, ABNORMAL OUTPUT, ABNORMAL OPERATION, ABNORMAL APPEARANCE, ETC.) OR MALFUNCTION BE OBSERVED WHILE USING THE THUNDERBEAT, STOP THE USE AND WITHDRAW THE INSTRUMENTS FROM THE BODY CAVITY. DO NOT WITHDRAW THE TRANSDUCER PLUG FROM THE ULTRASONIC GENERATOR. CHECK THE EQUIPMENT BY REFERRING TO CHAPTER 8, ¿TROUBLESHOOTING¿, IN THE INSTRUCTION MANUAL FOR THE ULTRASONIC GENERATOR. IF THE IRREGULARITY REMAINS AFTER TROUBLESHOOTING, REPLACE THE TRANSDUCER. IF THIS DOES NOT RESOLVE THE ISSUE, REPLACE THE THUNDERBEAT INSTRUMENT. IF THE IRREGULARITY REMAINS UNRESOLVED, CONTACT OLYMPUS. *IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED TISSUE 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS 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

    DURING AN ESOPHAGECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE ACTIVE BLADE BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE ACTIVE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126748 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR844447 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1