BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 5992881 · Received October 2, 2016

    Report

    Report Number
    8010047-2016-01243
    Event Type
    Malfunction
    Date Received
    October 2, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 3, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD WAS WORN AND PARTIALLY SEPARATED. BOTH THE PROBE TIP AND THE GRASPING SECTION HAD CONTACT MARKS WITH EACH OTHER. THE COATING OF GRASPING SECTION WAS PARTIALLY MISSING. THE PROBE WAS NOT BROKEN. WHEN WE CLOSED THE GRASPING SECTION AND ACTIVATED SEAL MODE, SHORT CIRCUIT ERROR WAS REPRODUCED. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THIS TYPE OF THE COATING DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE COATING OF GRASPING SECTION WAS DAMAGED WHEN THE USER SCRAPED TISSUE OR COAGULUM ON THE GRASPING SECTION WITH A SHARP OBJECT. THE INSTRUCTION MANUAL OF THE DEVICE ALREADY CAUTIONS; WHEN TISSUE OR COAGULUM BUILD-UP, ON THE GRASPING SECTION OR THE PROBE TIP, USE A PIECE OF MOISTENED, SOFT GAUZE TO CLEAN THE GRASPING SECTION OR PROBE TIP. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL. OTHERWISE, THE GRASPING SECTION, PTFE PAD OR THE PROBE TIP MAY BE SCRATCHED, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY DURING TREATMENT. THIS REPORT IS ONE OF THE TWO REPORTS. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2016-01237.

    Description of Event or Problem · 1

    DURING A GASTRECTOMY, THE SUBJECT DEVICE WAS USED. AFTER AN HOUR OF USE, UNSPECIFIED ERROR OCCURRED AND THE PTFE PAD OF THE DEVICE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT. THERE WAS NO PATIENT INJURY REPORTED. AFTER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE SUBJECT DEVICE FOR EVALUATION, OMSC CONFIRMED THAT THE COATING OF GRASPING SECTION WAS PARTIALLY MISSING ON (B)(6) 2016. AND IT WAS NOT REPORTED THAT THE FRAGMENT OF THE COATING FELL INTO THE PATIENT. THIS MDR IS REGARDING THE MISSING OF THE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644245 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC 66K

    Patients

    Seq Age Sex Outcome Treatment
    1