BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP

    MDR report key: 16828211 · Received April 27, 2023

    Report

    Report Number
    9610773-2023-01164
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 28, 2023
    Report Date
    October 9, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761068236
    PMA / PMN Number
    K100275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE IS MOST LIKELY DUE TO THE APPLICATION OF EXCESSIVE FORCE. IN GENERAL, THE CUSTOMER IS REQUIRED TO CHECK THE FUNCTION OF ALL DEVICES USED PRIOR TO A PROCEDURE. ADDITIONALLY, ACCORDING TO THE INSTRUCTIONS FOR USE, A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED DURING AN APPLICATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K120418.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT AN HF-RESECTION ELECTRODE LOOP SUFFERED TOO MUCH MECHANICAL MANIPULATION AND WHEN ACTIVATED WITH THE HF ENERGY IT BROKE AND THERE WAS SMOKE. AN ENDOSCOPIC SEARCH WAS CARRIED OUT IN THE UTERINE CAVITY AND PIECES OF MATERIAL WERE FOUND. THE DEBRIS WAS ABLE TO BE RECOVERED FROM THE UTERINE CAVITY AND THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS A THERAPEUTIC HYSTEROSCOPY WHICH WAS COMPLETED USING A SIMILAR DEVICE. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464965 HF-RESECTION ELECTRODE, LOOP ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22507D 1000082810 14042761068236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown