BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOBOAT BIPOLAR PORT

    MDR report key: 24198422 · Received January 27, 2026

    Report

    Report Number
    MW5182891
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Report Date
    January 23, 2026
    Manufacturer
    PETER LAZIC US INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE UNIT'S BIPOLAR PORT WAS NOT WORKING AND THE UNIT STARTED OPERATING AUTOMATICALLY WHEN A BIPOLAR INSTRUMENT WAS CONNECTED. THERE WAS NO PATIENT INJURY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257084 HOBOAT BIPOLAR PORT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI PETER LAZIC US INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown