BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS

    MDR report key: 18988746 · Received March 27, 2024

    Report

    Report Number
    9610773-2024-00879
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    March 13, 2024
    Report Date
    August 2, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761085530
    PMA / PMN Number
    K171965
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-00209-01.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO PROVIDE AN UPDATE TO FIELD H4. 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, IT WAS LIKELY, THAT THE REPORTED EVENT OCCURRED, DUE TO WEAR AND TEAR. ADDITIONALLY, THE LOOP AT THE DISTAL END OF THE ELECTRODE WEARS OUT, DURING USE AND MAY BREAK, BURN OR MELT. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED. AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-00209.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE LOOP BROKE AT THE END OF THE PROCEDURE AND WAS REMOVED BY TRAPPING THE WIRE WITH THE END OF THE RETRACTABLE LOOP ARM WITHOUT ANY CAUTERY ACTIVATED. ANOTHER SURGEON THEN PROCEEDED WITH THE PATIENT'S BREAST SURGERY. THERE WAS NO DELAY AS THE X-RAY WAS DONE AT THE END OF THE COMPLETED CASES, NOT IN BETWEEN.

    Description of Event or Problem · 0

    IT WAS REPORTED, DURING A THERAPEUTIC HYSTEROSCOPY/MYOMECTOMY PROCEDURE USING THE LOOP CAUTERY, THE LOOP BROKE AT THE CONNECTION POINT TO THE ELECTRODE. THE SURGEON VISUALIZED THE UTERINE CAVITY THE ENTIRE TIME FROM THE BREAK TO THE RETRIEVAL AND THE LOOP ITSELF WAS RETRIEVED, INTACT, FROM THE UTERINE CAVITY. THERE WERE NO FURTHER FOREIGN BODIES VISUALIZED AFTER THE RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A FLUOROSCOPY X-RAY OF THE PELVIS/UTERINE CAVITY WAS TAKEN, FOLLOWED BY A FLAT P LATE X-RAY AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985311 HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS RESECTION ELECTRODES WITH HF CABLE FAS OLYMPUS WINTER & IBE GMBH WA47706S 1100442429 14042761085530

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention