BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL ELECTRODE, UNIVERSAL SIZE, WITHOUT CABLE

    MDR report key: 21168254 · Received January 16, 2025

    Report

    Report Number
    9610773-2025-00468
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 17, 2024
    Report Date
    May 28, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    14042761085875
    PMA / PMN Number
    K173877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00033. THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00033-01. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION, ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, UPON FURTHER FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT SUFFER ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE, THUS CORRECTING B1, B2, AND H1. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED. THE H6 MEDICAL DEVICE PROBLEM REPORTED AND OTHER FINDINGS WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE NEUTRAL ELECTRODES THAT WERE RETURNED DID NOT PROVIDE THE CABLE FOR TESTING. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, THE CAUTERY COULD NOT BE APPLIED WITH THE USE OF THE SUBJECT DEVICE. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. IT WAS THEN COMPLETED WITH THE USE OF A COMPETITOR DEVICE. THERE WERE NO REPORTS OF ADVERSE PATIENT SEQUELAE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER CONFIRMED THAT THERE WAS NO EVIDENCE THE PATIENT SUFFERED ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892683 NEUTRAL ELECTRODE, UNIVERSAL SIZE, WITHOUT CABLE WA99516A GEI OLYMPUS WINTER & IBE GMBH WA99516A 314-576 14042761085875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown