BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 4274230 · Received November 7, 2014

    Report

    Report Number
    2951238-2014-00487
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    OLYMPUS WINTER AND IBE GMBH
    Product Code
    GEI
    PMA / PMN Number
    K073207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF NEW INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE, THE UNIT WAS TURNED ON WITH AN INITIAL SETTING OF 15 WATTS, BUT WOULD NOT CUT. THE POWER WAS INCREASED TO 20 WATTS AND THEN TO 25 WATTS. IT WAS NOTED THAT THE MUCOSA AROUND THE POLYP AREA STARTED CHANGING FROM A WHITE TO A GRAY COLOR, AS IF THE HEAT WAS SPREADING IN THE MUCOSA. THE PT STARTED TO COMPLAIN ABOUT FEELING PAIN IN THE RIGHT HIP WHERE THE NON OLYMPUS PLATE WAS LOCATED. THE POLYPECTOMY COULD NOT BE PERFORMED AFTER THREE ATTEMPTS. THE PHYSICIAN REPLACED THE ELECTROSURGICAL UNIT WITH THEIR OWN PSD-10 UNIT. THE INTENDED POLYPECTOMY PROCEDURE WAS COMPLETED SUCCESSFULLY. OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND IT WAS REPORTED THAT THE PT REPORTED NUMBNESS IN THE RIGHT HIP AREA. IT WAS STATED THAT THE PT WAS GIVEN CIPRO 500 MG AND DISCHARGED THE DAME DAY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717137 ELECTROSURGICAL GENERATOR GEI OLYMPUS WINTER AND IBE GMBH ESG-100 (WE991046) 16930W23-101

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention MACROLITE CONMED PT PLATE REF# (B)(4)